Proposal for a Council Decision on the conclusion of an Agreement on mutual recognition in relation to conformity assessments, between the European Community and the United States of America
COMMISSION OF THE EUROPEAN COMMUNITIES Brussels, 30. 03. 1998 COM(1998) 180 final 98/0105 (ACQ Proposal for a COUNCIL DECISION on the conclusion of an Agreement on Mutual Recognition in relation to Conformity Assessments, between the European Community and the United States of America (presented by the Commission) EXPLANATORY MEMORANDUM I. The Agreement On the basis of the negotiating directives issued by the Council on 21. 9. 92. the European Commission has negotiated and initialled an Agreement on the mutual recognition of conformity assessment (Mutual Recognition Agreement, or MRA) with the US. A Text of the Agreement initialled in June 1997 is annexed. This memorandum provides an assessment of the Agreement in the light of the negotiating directives approved by the Council, and recommends that the Council decides to approve the Agreement by means of a Council decision to that effect. LI Assessment of the Agreement The Commission considers that the initialled Agreement, is in conformity with the Council's negotiating directives, takes account of the views expressed by the 113 MRA Committee, which gave detailed advice to the Commission during the negotiations, and provides benefits to the European Community. The Agreement does not contain a rule of origin. As for Canada this proved to be non-negotiable with the United States. Member States are in the process of designating a considerable number of conformity assessment bodies (CABs). Once these bodies have been provisionally accepted by the United States, subject to formal acceptance by decision of the Joint Committee, the Council Secretariat will receive this list of CABs by way of a Commission Staff paper. Sufficient confidence exists between the Parties to the Agreement to allow them to proceed. 1. 1. 1 Framework Agreement The Agreement consists of a framework agreement and a series of sectoral annexes. An article-by-article assessment of the framework follows: Pre-amble : this sets out the basic objectives of mutual recognition agreements in terms of trade facilitation. Article 1: Definitions: these are self-explanatory. no _ Article 2: Purpose: this article lays down the objective of the Agreement, i. e. effective market access through the recognition of results of conformity assessments. It provides the basis for terminating the Agreement, should market access be denied. Article 3: General Obligations: this article sets out the obligation of each Party to accept the results of conformity assessments carried out to its requirements by the other Party, according to the terms of the sectoral annexes. Notably, the provision establishes acceptance of product certifications and authorisations of each Party. This Article also establishes the link between the basic obligations of the Agreement and. its sectoral annexes. Article 4: General Coverage: this article provides that the conformity assessment procedures to which the Agreement applies are specified in the individual sectoral annexes, and describes the content of the annexes. transitional Article 5: Transitional Arrangements: arrangements set out in the annex, to the necessity of a time period for completion and the possibility of amending it, and the need to move to full implementation by the end of the period unless there is documentary evidence that the conditions for a successful transition are not met. this Article refers the to Article 6: Designating Authorities: this is a key provision requiring designating authorities to have the necessary formal powers over the bodies they designate. This article thus provides a guarantee that US has the necessary authority to designate, suspend or withdraw bodies. Article 7: Designating and Listing Procedures: this article refers to the procedures which apply for the designation of conformity assessment bodies, the way additional bodies should be proposed, the time period for accepting or rejecting new designations and the role of the Joint Committee in this respect. Article 8: Suspension of Listed Conformity Assessment Bodies: this article establishes the right for one Party to challenge the compliance of bodies in the other Party. Verification will be carried out by the Party in whose territory the CAB is located. The CAB will be suspended where disagreement over its status has been confirmed by the Joint Committee, unless otherwise decided by that Committee. As advised by the Member States in the 113 Committee MRA Group, the right of verification has been closely circumscribed to prevent it being carried out routinely or unilaterally. Article 9: Withdrawal of Listed Conformity Assessment Bodies: this article establishes a detailed procedure and timing for the withdrawal of conformity assessment bodies, including on the continued acceptance of the results of conformity assessments carried out before their withdrawal. Article 10: Monitoring of Conformity Assessment Bodies: this article contains a commitment, from designating authorities, to ensure the continued capability of conformity assessment bodies to assess products or processes. Article 11: Conformity Assessment Bodies (CABs): this article states that CABs listed in the Agreement are deemed fulfilling their conditions of eligibility for the listed assessment procedures. 03 Article 12: Exchange of Information: a basic transparency provision. Article 13: Sectoral Contact Point: this provides for the designation of contact points to be responsible for activities under each sectoral annex. Article 14: Joint Committee: this article requires the establishment of a Joint Committee to administer the Agreement on behalf of the Parties. Duties of the Joint Committee include designation of Joint Sectoral Committees and the adoption of voting systems. It includes the procedure for formally adopting changes to the Sectoral annexes to add or remove conformity assessment bodies, and discussing divergence of view. New conformity assessment procedures applying to covered products will be brought within the scope of the Agreement so as to preserve negotiated market access benefits. This article does not give the Joint Committee the right to extend the scope and coverage of the agreement to include new sectors. This has to be mandated by the Parties. Article 15: Preservation of Regulatory Authority: this article confirms that the Agreement has no effect on each party determining its own level of protection for human, animal and plant life or health. It provides for a safeguard clause allowing each Party to take urgent measures providing they inform their counterpart authority within fifteen days and give the reason for. Article 16: Suspension of recognition obligations: is a key provision authorising each Party to suspend its obligations in case of loss of market access or failure, by the other Party, to maintain authorities capable of implementing the provisions of the Agreement. Article 17: Confidentiality: this article, debated at length, leaves to the legislation of the importing. Party to determine the extent of confidentiality of information transmitted. Trade secrets, confidential commercial or financial information and information relating to ongoing investigation may not be disclosed to the public. It leaves to the exporting party the right to designate the portions of information that should be exempt from disclosure. Article 18: Fees: this provides that a Party shall not charge fees for conformity assessments carried out by other Parties in accordance with the Agreement and that any fees charged will be commensurate with the services provided. Article 19: Agreements with other countries: this article provides that any Mutual Recognition Agreement between a Party to this Agreement and other countries shall have no force in regard to the other Party to this Agreement. Article 20: Territorial application: this article confirms that the Agreement applies only to the territories of the European Community and the US. Article 21: Entry into force, amendment and termination: this article lists all sectors covered in the current Agreement and states that the Agreement will enter into force on the first day of the second month following the exchange of letters confirming the signature of the Agreement, that additional annexes, if any, will enter into force 30 days after the relevant exchange of letters, and that the Agreement may be terminated by giving the other party six month notice. With Article 16, this article contains a key 04 _ provision on termination of the entire Agreement in case there is no agreement on the termination of a certain annex. Articles 22: Final provisions: these are standard institutional and legal provisions. It should be noted that the Agreement is of unlimited duration. 1. 1. 2 The Sectoral Annexes There follows an assessment of the content of each sectoral annex in terms of its coverage, the type of mutual recognition arrangements envisaged for the sector, and the trade and other implications. In making this assessment, the Commission has kept in mind the following elements: a) whether the sectoral annex provides for genuine mutual recognition, i. e. whether all relevant conformity assessment procedures for a particular sector have been captured; b) c) d) e) the level of trade between the Community and US for the sectors and products covered; the views expressed by Member States and European industry groups on the benefits of mutual recognition; the precedential nature (if any) of arriving at a mutual recognition agreement with US in the sectors covered; overall consistency with Community policy objectives field of standardisation, certification, designation of Conformity Assessment Bodies and the removal of technical barriers to trade. the in The sectoral assessment is followed by an overall appreciation of the benefits of the Agreement. The Commission draws Member States' attention to the trade figures for each covered sector in the Annex to this note. These figures show that for every sector concerned, with the exception of medicinal products, the US have a small trade surplus with the Community. Third party certification (the subject of the MRA) applies most commonly to industrial products at the higher end of technology, in respect of which both the Community and US are major exporters. A priori, this may indicate that the trade facilitation benefits of the Mutual Recognition should accrue to both the Community and the US. We note however, that trade flows only give a partial picture of the likely benefits. The balance of benefits depends on additional factors, in particular the following: a) trade facilitation benefits the range of products within a sector subject to third party certification. Obviously, if in a given sector one Party has more comprehensive certification requirements, the i. e. exporting Party may be proportionately greater. In this respect, the tendency for deregulation seems to be more important in the EU and manufacturers' declarations of conformity are more used in the EU (e. g. for electrical safety, recreational crafts); the other to 05 b) the complexity and accessibility of the conformity assessment requirements of each Party, including the extent to which each Party applies internationally recognised standards or technical requirements for the sector in question. This may be an issue in various sectors in the case of US which have a fair number of non internationally harmonised standards and requirements. The Commission notes that industrial groups consulted throughout the negotiations (such as EUROBIT, ORGALIME, EFPIA), while supporting the agreements, have not been able to quantify the costs or time taken by conformity assessment of an entire class of products at import in the US or in the EU. It is therefore not feasible in every case to determine the extent of savings in time, cost or market opportunity of the arrangements set out in this Agreement. This may only be possible once the Agreement has been in operation for some time. What can be ascertained however is whether we have addressed industry's concern that this Agreement provides reciprocal levels of market access, in terms of conformity assessment procedures. The Agreement also presents important advantages from the point of transparency, market access, avoidance of duplication especially of cost, and general facilitation of trade. This is of particular importance for small and medium sized companies. On the basis of a rough calculation it is estimated that this Agreement will create cost savings for the exporting industry of at least 190 MECU and an equivalent amount in terms of cost savings to exporters to the EU, some part of which will be passed on to European importers or consumers. Where relevant, the above factors are taken into account in the assessment of each sectoral annex. Telecommunication Equipment relevant Community Directives, This annex concerns all telecommunications terminal equipment (TTE) regulated under the as non-harmonised Member States'legislation for analogue connection to public networks and radiotransmitters for civilian applications, and the corresponding US legislation. Both sectoral annexes on electrical safety and electromagnetic compatibility apply also to the products covered by this annex. as well Through the Agreement, the regulatory authorities of the parties recognise the conformity assessment certificates and test reports issued by the Conformity Assessment Bodies to be listed in Section V. The Conformity Assessment Bodies will be required to comply with the criteria and standards set out in the regulatory requirements of the other Party (set out in Section VI). A list of Designating Authorities is given in Section IV. A Joint Sectoral Committee is set up to discuss technical, conformity assessment and technology issues relating to this annex and the one on electromagnetic compatibility. The annex provides for a transitional period of 24 months to build confidence in and understanding of each other's system for designating and listing CABs and in the ability of these bodies to test and certify products. It provides for the reciprocal recognition of test reports issued by designated CABs during the transitional period under certain conditions. This transitional period will also be used to consider legislative changes needed and initiate them to support the objectives of the agreement. There is a provision for the organisation of two seminars, during the first year of operation of the transition « 06 arrangements, on technical and product approval requirements. At the end of the transitional period the Parties will grant full mutual recognition of compliance certificates. European the MRA industry organisations have been consulted extensively on negotiations and have supported the approach, namely the logic built in between this annex and the annex on electrical safety, i. e. that this annex would only operate once enough CABs have been accepted for recognition. This provision ensures indeed a balanced access to both markets. The agreement does provide for reciprocal recognition of all conformity assessment procedures including final certification without further product assessment by the importing party. Electrical Safety This annex covers the testing and certification requirements set out in the EC's Low Voltage Directive and corresponding US regulations, including medical devices, telecommunication equipment and their electromagnetic compatibility aspects, and except products certified or approved under the Federal Mine Safety and Health Act. A Joint Sectoral Committee is set up by section VII, with OSHA representing the US. Sections IV and V of the annex list the authorities responsible for designating the CABs and the CABs themselves (an initial list of CABs has to be included when the agreement is implemented). Section VI describes the procedures for designating and suspending the CABs. OSHA (Occupational and Safety Health Administration) will validate within 30 days application dossiers and confirm CABs in Section V within 120 days. OSHA will rely on the EC designating Authorities for conducting on-site reviews at the respective Member States' CABs. This is a major improvement vis-à-vis the current situation. OSHA also agreed to consider regulatory and legislative changes needed to support the objective of an MRA. European industry groups have been consulted on the proposed MRA and have expressed support provided that we ensure that any agreement provides for reciprocity of market access and does not lead to the introduction of new and more onerous requirements. Given the existing openness of the EC regime, and the fact that the necessary US legislation is covered under the sectoral annex, these requirements have clearly been met. While manufacturers' self certification exists in the EC, third party certification is required for certain categories of products in the US and there are therefore clear advantages in the Agreement from an EC perspective. Electromagnetic Compatibility (EMC) In view of the "horizontal" application of EMC requirements to a wide range of electrical, machinery and telecommunications products, coverage of the EMC phenomenon in the MRA is necessary to achieve the objective of covering all relevant conformity assessment procedures. Each Party agrees to recognise the other Party's results of the conformity assessment procedures carried out by the CABs listed in section V of the annex, as required under their respective legislation, without any further assessment of the products. The Agreement also provides for a transitional arrangement of 24 months. During this period the Parties will work together to ensure familiarity with each other's regulatory • 07 requirements, exchange information and review the work carried out by designated Conformity Assessment Bodies and demonstrate to each other's satisfaction their capability to carry out conformity assessment to the requirements of the other Party. During the first year of operation of the agreement,, the parties may jointly sponsor two seminars on the relevant technical and product approval requirements. Recreational Craft The sectoral annex for recreational craft applies to all recreational craft, including personal watercraft, which are subject to third party certification in the European Community or US. The Agreement covers all relevant legislation (Directive 94/25) and the Federal regulations in US. Both sectoral annexes on electrical safety and electromagnetic compatibility apply also to the products covered by this annex. The Parties will recognise certificates issued by each other's designated Conformity Assessment Bodies without any further assessment of the products to which they relate. A list of Designating Authorities is given in Section 3. The Conformity Assessment Bodies will be required to comply with the criteria and standards set out in the regulatory requirements of the other Party (set out in Section 4). The Conformity Assessment Bodies are to be listed in Section 5. The annex provides for a transitional arrangement of 18 months in which the Parties will cooperate to establish a system for designating CABs and build confidence in the ability of these bodies. During this period, they will exchange information on technical data and conformity assessment procedures, developing greater familiarity with their respective regulatory requirements, and carry out the legislative and regulatory changes necessary for the provisions of their annex. During this period, the parties shall endeavour to sponsor seminars for the purpose of improving the understanding of the respective technical requirements. Pharmaceuticals Good Manufacturing Practice (GMP) This annex establishes mutual recognition of each Party's inspections of pharmaceutical sites according to the GMP standards of each, which, subject to further verification during the transition phase, have been declared '"equivalent" by the Steering Committee of the International Conference on Harmonisation. Recognition of inspection results is not automatic. Inspection reports will have to be transmitted and "normally endorsed" by the importing party except under specific and delineated circumstances. Endorsement of each other's inspection reports should remove the need for companies in each Party to be inspected by the authorities of the other Party. The products traded need no further batch. testing and control upon import, except for biologicals, when an official batch release procedure applies (also called lot-by-lot testing); in this case, controls are carried out by the authorities. The scope of the annex covers all medicinal products regulated by both parties, except veterinary biologicals, which are regulated by a different US Agency (APHIS). A separate annex to the agreement is being negotiated for these products. Human plasma derivatives, investigational medicinal products, radiopharmaceuticals and medicinal gases are not included in the transitional arrangements and their situation will be 08 reconsidered at the end of the transition phase. An indicative list of such products is also included (appendix 3 of sectoral annex). This annex applies only to pharmaceutical products subject to GMP in either Party. This permits inspections to be carried out against each Party's domestic GMP standard in most cases. The annex lists the applicable legislation and relevant certifying authorities. It also sets out in appendices 4 and 5 to the sectoral annex, the criteria for assessing equivalence of post- and pre-approval inspections and the elements to be considered in developing an alert system. It sets up a Joint Sectoral Committee. A three-year transition period is aimed at determining the equivalence of the "regulatory systems". All authorities are requested to actively participate in the determination of equivalence exercises in order to build a sufficient body of evidence for their equivalence determination. At the beginning of the transition period, the parties will exchange their draft programmes. Their implementation will permit the determination of the capacity of each Party's authority to perform GMP inspections and ensure the appropriate enforcement. At the end of this period, a list of authorities deemed equivalent will be agreed by the Joint Sectoral Committee and any insufficient evidence of equivalence, lack of opportunity to assess equivalence or determination of non-equivalence will have to be documented in sufficient detail. European industry and Member States' inspection authorities (Working Group on Inspection and control of medicinal products, and the Pharmaceutical Committee) have been consulted at every step of the negotiation and support the arrangements negotiated. This agreement provides mutual benefits to pharmaceutical companies, and some savings to inspection authorities. The present agreement also establishes mechanisms for longer- term cooperation between respective inspection authorities which will not only ensure the agreement continues to be properly applied, but will stimulate further harmonisation initiatives. The Community and the US are important trade partners in this sector and trade is well balanced (see Annex 4) as well as the benefits expected from the Agreement. Medical Devices This annex establishes mutual recognition of the results of quality-system-related evaluations and inspections and pre-market evaluations as conducted by listed conformity assessment bodies (CABs); it provides also for other related co-operative activities such as an exchange of post-market vigilance reports with regards to all products regulated under both US and EC legislation. This recognition is not automatic. Various types of reports will have to be transmitted; they will be "normally endorsed" by the importing party, except under specific and delineated circumstances. Endorsement of each other's reports should remove the need for companies in each Party to be inspected and their application files be re-assessed by the authorities of the other Party. 09 Product coverage, within the two Community Directives for medical devices, and for US their domestic legislation in this field, is determined in the annexes of the agreement and varies according to the nature of the evaluation and the phase of the agreement. For quality systems evaluations, the agreement covers all products regulated under both EU and US legislation. For products evaluations (product approvals), the scope is limited to those products classified under the US system as Class I/Class II - Tier 2 which are listed in Appendix 2 of the sectoral annex. The annex thus covers all conformity assessment procedures in the Parties, including final certification and approval for the products listed in the agreement. The annex provides for a transition period (3 years) which will evaluate the capabilities of the proposed Conformity Assessment Bodies. Conformity Assessment Bodies willing to participate in the confidence-building activities and meeting the criteria for technical competence and independence will be designated by each party and listed in Appendix 4. At the end of the transition period, the CABs will be jointly confirmed in an Appendix 5. Any "non-confirmation" of a proposed CAB would have to be justified based on documented evidence. A Joint Sectoral Committee is set up and at the beginning of the transition period, it will establish a joint confidence building programme including seminars, workshops, joint training exercises, observed inspections and the design of an appropriate system of exchange of information. The Parties will, during the transition, work to harmonise the necessary information which must be present in quality systems, and product evaluation reports; they will also develop a notification and alert system. An annual report will describe the progress of the exercise. Harmonisation activities will include participation in the Global Harmonisation Task Force and the utilisation of its results. The requirements of third party premarket assessment are extensive on both sides and cover up to 90% of the field. In this respect therefore we consider that the agreement presents a balance of advantages to both parties. In the light of the above, we believe European industry is content with the proposed MRA in this sector. It is worth mentioning that the US Senate Committee on Labor and Human resources recently stated that the MRA "will lay a flagstone in the path being built toward harmonization activities on things like increase reliance on international standards". The Commission considers that the MRA in this sector sets the right precedents in terms of our long term objectives. All certification procedures are covered and the product coverage will extend with time. 1. 1. 3 Relations with EFTA States, members of the European Economic Area In accordance with the general information and consultation procedures set out in the EEA Agreement and Protocol 12 of the said Agreement, the Commission has kept EFTA / EEA States regularly informed about developments in the negotiations and has informed them on the final result of the negotiations. The EFTA / EEA States have had preliminary talks with the US for negotiating a mutual recognition agreement equivalent to the one to be concluded between the Community and the US. 10 1. 1. 4 Overall Appreciation The Commission considers that the proposed MRAs create an acceptable balance of benefits for all parties overall, when all sectors are taken together. The overall trade balance with the US and the nature of the current certification procedures in the US would also suggest that the Agreement will bring a number of improvements for EC exporters. In all sectors the Community has secured effective market access - in terms of access to all mandatory procedures of the other party. US has accepted the Community's approach of reciprocally recognising not only testing, but also certificates and approvals of conformity to the other's requirements. The agreement will allow Community exporters, if they so choose, to test and certify their products to US requirements prior to export, and then access those markets without any further conformity assessment requirements. This will facilitate Community exports. European industry federations have been consulted on the Agreement and have supported it. The Commission has received indications that a large number of EC conformity assessment bodies would be interested to work in the framework of this Agreement, and this indicates both their technical capacity and economic interest in the Agreement. In several sectors the Agreement caters for the further development of the parties' regulatory regimes, with the aim of ensuring that future rules do not undermine the benefits of the agreement. And in several sectors, the agreement will help to promote wider acceptance of the Community's regulatory approach and technical requirements. II. Proposal for a Council Decision A proposal for a Council decision on the conclusion of the Agreement is attached. The decision has two objectives: a) to approve, on the basis of Articles 113 and 228 of the Treaty, the draft Agreement; and b) to establish the appropriate Community procedure to enable the Commission, assisted by the 113 Committee (Technical Group on Mutual Recognition), to represent the Community in the Joint Committee and the Joint Sectoral Committees established by the Sectoral Annexes and that the Community position in that Joint Committee and in the Joint Sectoral Committees in case of changes to the Annexes and other sectoral questions be determined in conformity with Article 228, paragraph 4 of the Treaty, by the Commission in consultation with the 113 Committee. On this second aspect, it is noted that in Article 14 of the Agreement, a Joint Committee of the Parties operates. This Joint Committee is responsible for the management of the Agreement and has the delegated power to amend existing sectoral annexes. Such right of amendment is restricted only to procedural issues concerned with implementation, essentially: amending the references to the regulations applicable to covered sectors; amending the annexes further to decisions to recognise, suspend, remove, or alter the scope of activity of conformity assessment bodies or designating authorities in the Agreement. The power to amend the framework agreement, to delete sectoral annexes or to add new sectoral annexes rests with the Parties. It is accordingly proposed that: 11 « a) the Commission, assisted by the 113 Committee (Technical Group on Mutual Recognition) should represent the Community in the Joint Committee and in the Joint Sectoral Committees established by the Sectoral Annexes, and that the Community position in that Joint Committee and in the Joint Sectoral Committees in case of changes to the annexes and other sectoral questions be determined, in conformity with Article 228, paragraph 4 of the Treaty, by the Commission following consultation of the above mentioned committee. b) for all other issues, the Community position shall be determined by the Council, acting by qualified majority on a proposal from the Commission. The Commission therefore proposes that the Council adopts the appended decision, and indicates the person who, on behalf of the Community, signs the Agreement. I& Proposai for a Council Decision on the conclusion of an Agreement on Mutual Recognition in relation to Conformity Assessments, between the European Community and the United States of America (. /. /EC) The Council of the European Union, Having regard to the Treaty establishing the European Community, and in particular Article 113 in conjunction with Article 228, paragraph (2), (3) first paragraph and (4) thereof, Having regard to the proposal of the Commission, Whereas the Agreement on Mutual Recognition in relation to Conformity Assessment, between the European Community and the US, initialled in Brussels on 20 June 1997, has been negotiated and should be approved, Whereas certain tasks for implementation have been attributed to the Joint Committee established by the Agreement, and in particular the power to amend the Sectoral Annexes thereto; Whereas the appropriate internal procedures should be established to ensure the good functioning of the Agreement, and whereas it is therefore necessary to delegate to the Commission the power to proceed to certain technical amendments of the Agreement and to take certain decisions for its implementation, Decides: Article 1 The Agreement on Mutual Recognition in relation to Conformity Assessment between the European Community and US, including its Annexes are hereby approved on behalf of the European Community. The text of the Agreement and the Annexes are attached to this Decision. Article 2 The President of the Council shall, on behalf of the Community, transmit the letter provided for in Article 21 of the Agreement1 1 The date of the entry into force of the Agreement will be published in the Official Journal of the European Communities. d3 # Article 3 1. The Commission shall represent the Community in the Joint Committee provided for in Article 14 of the Agreement, and in the Joint Sectoral Committees established by the Sectoral Annexes, assisted by the special committee established under Article 113 of the EC Treaty (Mutual Recognition). The Commission shall proceed, after consultation with this committee, to the appointments, notifications, exchange of information and the requests for verifications referred to in Article 10, letter b), 12, 13 and 14 paragraph 2 of the Agreement and the equivalent provisions of its Sectoral Annexes. 2. 3. The position of the Community in regard of decisions to be taken by the Joint Committee or if appropriate in the Joint Sectoral Committees shall be determined, with regard to amendments of the Sectoral Annexes (Article 14, paragraph 4, letter b), and Articles 7, 8 and 9 of the Agreement and the equivalent provisions of its Sectoral Annexes, and verification of compliance in accordance with Article 7 d) of the Agreement by the Commission, following consultation of the above mentioned special committee. In all other cases the position of the Community for a decision in the Joint Committee or Joint Sectoral Committees shall be determined by the Council, acting by qualified majority on a proposal from the Commission. The same procedure shall apply to decisions taken by the EC in the framework of Articles 16 and 21. Done at Brussels, For the Council The President 14 AGREEMENT ON MUTUAL RECOGNITION BETWEEN THE UNITED STATES OF AMERICA AND THE EUROPEAN COMMUNITY Electromagnetic Compatibility (EMC) Page 29 TABLE OF CONTENTS •» 1. Framework Telecommunication Equipment 2. 3. 4. 5. 6. Electrical Safety Recreational Craft Pharmaceutical Good Manufacturing Practice (GMP) 7. Medical Devices Page 1 Page 15 Page 39 Page 49 Page 55 Page 71-113 15 Initialled on 20 June 1997 AGREEMENT ON MUTUAL RECOGNITION BETWEEN THE UNITED STATES OF AMERICA AND THE EUROPEAN COMMUNITY The Government of the United States of America and the European Community, hereinafter referred to as "the Parties ", Considering the traditional links of friendship that exist between the United States of America (U. S. ) and the European Community (EC); Desiring to facilitate bilateral trade between them; Recognizing that mutual recognition of conformity assessment activities is an important means of enhancing market access between the Parties; Recognizing that an agreement providing for mutual recognition of conformity assessment activities is of particular interest to small and medium-sized businesses in the U. S. and the EC; Recognizing that any such mutual recognition also requires confidence in the continued reliability of the other Party's conformity assessments; Recognizing the importance of maintaining each Party's high levels of health, safety, environmental and consumer protection; Recognizing that mutual recognition agreements can positively contribute in encouraging greater international harmonization of standards; Noting that this Agreement is not intended to displace private sector bilateral and multilateral arrangements among conformity assessment bodies or to affect regulatory regimes allowing for manufacturers' self-assessments and declarations of conformity. I l fi u x Initialled on 20 June 1997 Bearing in mind that the Agreement on Technical Barriers to Trade, an agreement annexed to the Agreement establishing the World Trade Organization (WTO), imposes obligations on the Parties as Contracting Parties to the WTO, and encourages such Contracting Parties to enter into negotiations for the conclusion of agreements for the mutual recognition of results of each other's conformity assessment; Recognizing that any such mutual recognition needs to offer an assurance of conformity with applicable technical regulations or standards equivalent to the assurance offered by the Party's own procedures; Recognizing the need to conclude an Agreement on Mutual Recognition (MRA) in the field of conformity assessment with sectoral annexes; and Bearing in mind the respective commitments of the Parties under bilateral, regional and multilateral environment, health, safety and consumer protection agreements. Have agreed as follows: Article 1 DEFINITIONS 1. The following terms and definitions shall apply to this Agreement only: Designating Authority means a body with power to designate, monitor, suspend, remove suspension of, or withdraw conformity assessment bodies as specified under this Agreement. Designation means the identification by a Designating Authority of a conformity assessment body to perform conformity assessment procedures under this Agreement. Regulatory Authority means a government agency or entity that exercises a legal right to control the use or sale of products within a Party's jurisdiction and may take enforcement action to ensure that products marketed within its jurisdiction comply with legal requirements. 2. Other terms concerning conformity assessment used in this Agreement shall have the meaning given elsewhere in this Agreement or in the definitions contained in Guide 2 (1996 edition) of the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC). In the event of an inconsistency between ISO/IEC Guide 2 and definitions in this Agreement, the definitions in this Agreement shall prevail. 17 Initialled on 20 June 1997 Article 2 PURPOSE OF THE AGREEMENT This Agreement specifies the conditions by which each Party will accept or recognize results of conformity assessment procedures, produced by the other Party's conformity assessment bodies or authorities, in assessing conformity to the importing Party's requirements, as specified on a sector-specific basis in the Sectoral Annexes, and to provide for other related cooperative activities. The objective of such mutual recognition is to provide effective market access throughout the territories of the Parties with regard to conformity assessment for all products covered under this Agreement. If any obstacles to such access arise, consultations will promptly be held. In the absence of a satisfactory outcome of such consultations, the Party alleging its market access has been denied, may, within 90 days of such consultation, invoke its right to terminate the Agreement in accordance with Article 21. Article 3 GENERAL OBLIGATIONS The United States shall, as specified in the Sectoral Annexes, accept or recognize results of specified procedures, used in assessing conformity to specified legislative, regulatory, and administrative provisions of the United States, produced by the other Party's conformity assessment bodies and/or authorities. The European Community and its Member States shall, as specified in the Sectoral Annexes, accept or recognize results of specified procedures, used in assessing conformity to specified legislative, regulatory and administrative provisions of the European Community and its Member States, produced by the other Party's conformity assessment bodies and/or authorities. Where sectoral transition arrangements have been specified in Sectoral Annexes, the above obligations will apply following the successful completion of those sectoral transition arrangements, with the understanding that the conformity assessment procedures utilized assure conformity the satisfaction of the receiving Party, with applicable legislative, regulatory and administrative provisions of that Party, equivalent to the assurance offered by the receiving Party's own procedures. to Ie ^ Initialled on 20 June 1997 Article 4 GENERAL COVERAGE OF THE AGREEMENT 1. This Agreement applies to conformity assessment procedures for products and/or processes and to other related cooperative activities as described in this Agreement. 2. Sectoral Annexes may include: a) a description of the relevant legislative, regulatory and administrative provisions pertaining to the conformity assessment procedures and technical regulations; b) a statement on the product scope and coverage; c) a list of Designating Authorities; d) a list of agreed conformity assessment bodies or authorities or a source from which to obtain a list of such bodies or authorities and a statement of the scope of the conformity assessment procedures for which each has been agreed; e) the procedures and criteria for designating the conformity assessment bodies; f) a description of the mutual recognition obligations; g) a sectoral transition arrangement; h) the identity of a sectoral contact point in each Party's territory; and i) a statement regarding the establishment of a Joint Sectoral Committee. 3. This Agreement shall not be construed to entail mutual acceptance of standards or technical regulations of the Parties and, unless otherwise specified in a Sectoral Annex, shall not entail the mutual recognition of the equivalence of standards or technical regulations. 19 Initialled on 20 June 1997 Articles TRANSITIONAL ARRANGEMENTS The Parties agree to implement the transitional commitments on confidence building as specified in the Sectoral Annexes. 1. The Parties agree that each sectoral transitional arrangement shall specify a time period for completion. 2. The Parties may amend any transitional arrangement by mutual agreement. 3. Passage from the transitional phase to the operational phase shall proceed as specified in each Sectoral Annex, unless either Party documents that the conditions provided in such Sectoral Annex for a successful transition are not met. Article 6 DESIGNATING AUTHORITIES The Parties shall ensure that the Designating Authorities specified in the Sectoral Annexes have the power and competence in their respective territories to carry out decisions under this Agreement to designate, monitor, suspend, remove suspension of, or withdraw conformity assessment bodies. Article 7 DESIGNATION AND LISTING PROCEDURES The following procedures shall apply with regard to the designation of conformity assessment bodies and the inclusion of such bodies in the list of conformity assessment bodies in a Sectoral Annex: a) The Designating Authority identified in a Sectoral Annex shall designate conformity assessment bodies in accordance with the procedures and criteria set forth in that Sectoral Annex; b) A Party proposing to add a conformity assessment body to the list of such bodies in a Sectoral Annex shall forward its proposal of one or more designated conformity assessment bodies in writing to the other Party with a view to a decision by the Joint Committee; 20 Initialled on 20 June 1997 c) Within 60 days following receipt of the proposal, the other Party shall indicate its position regarding either its confirmation or its opposition. Upon confirmation, the inclusion in the Sectoral Annex of the proposed conformity assessment body or bodies shall take effect; and d) In the event that the other Party contests on the basis of documented evidence the technical competence or compliance of a proposed conformity assessment body, or indicates in writing that it requires an additional 30 days to more fully verify such evidence, such conformity assessment body shall not be included on the list of conformity assessment bodies in the applicable Sectoral Annex. In this instance, the Joint Committee may decide that the body concerned be verified. After the completion of such verification, the proposal to list the conformity assessment body in the Sectoral Annex may be resubmitted to the other Party. Article 8 SUSPENSION OF LISTED CONFORMITY ASSESSMENT BODIES The following procedures shall apply with regard to the suspension of a conformity assessment body listed in a Sectoral Annex: a) A Party shall notify the other Party of its contestation of the technical competence or compliance of a conformity assessment body listed in a Sectoral Annex and the contesting Party's intent to suspend such conformity assessment body. Such contestation shall be exercised when justified in an objective and reasoned manner in writing to the other Party; b) The conformity assessment body shall be given prompt notice by the other Party and an opportunity to present information in order to refute the contestation or to correct the deficiencies which form the basis of the contestation; c) Any such contestation shall be discussed between the Parties in the relevant Joint Sectoral Committee. If there is no Joint Sectoral Committee, the contesting Party shall refer the matter directly to the Joint Committee. If agreement to suspend is reached by the Joint Sectoral Committee or, if there is no Joint Sectoral Committee, by the Joint Committee, the conformity assessment body shall be suspended; d) Where the Joint Sectoral Committee or Joint Committee decides that verification of technical competence or compliance is required, it shall normally be carried out in a timely manner by the Party in whose territory the body in question is located, but may be carried out jointly by the Parties in justified cases; 21 ^ — Initialled on 20 June 1997 e) If the matter has not been resolved by the Joint Sectoral Committee within 10 days of the notice of contestation, the matter shall be referred to the Joint Committee for a decision. If there is no Joint Sectoral Committee, the matter shall be referred directly to the Joint Committee. If no decision is reached by the Joint Committee within 10 days of the referral to it, the conformity assessment body shall be suspended upon the request of the contesting Party; f) Upon the suspension of a conformity assessment body listed in a Sectoral Annex, a Party is no longer obligated to accept or recognize the results of conformity assessment procedures performed by that conformity assessment body subsequent to suspension. A Party shall continue to accept the results of conformity assessment procedures performed by that conformity assessment body prior to suspension, unless a Regulatory Authority of the Party decides otherwise based on health, safety or environmental considerations or failure to satisfy other requirements within the scope of the applicable Sectoral Annex; and g) The suspension shall remain in effect until agreement has been reached by the Parties upon the future status of that body. Article 9 WITHDRAWAL OF LISTED CONFORMITY ASSESSMENT BODIES The following procedures shall apply with regard to the withdrawal from a Sectoral Annex of a conformity assessment body: a) A Party proposing to withdraw a conformity assessment body listed in a Sectoral Annex shall forward its proposal in writing to the other Party; b) Such conformity assessment body shall be promptly notified by the other Party and shall be provided a period of at least 30 days from receipt to provide information in order to refute or to correct the deficiencies which form the basis of the proposed withdrawal; c) Within 60 days following receipt of the proposal, the other Party shall indicate its position regarding either its confirmation or its opposition. Upon confirmation, the withdrawal from the list in the Sectoral Annex of the conformity assessment body shall take effect; Z tj Initialled on 20 June 1997 d) e) In the event the other Party opposes the proposal to withdraw by supporting the technical competence and compliance of the conformity assessment body, the conformity assessment body shall not at that time be withdrawn from the list of conformity assessment bodies in the applicable Sectoral Annex. In this instance, the Joint Sectoral Committee or the Joint Committee may decide to carry out a joint verification of the body concerned. After the completion of such verification, the proposal for withdrawal of the conformity assessment body may be resubmitted to the other Party; and Subsequent to the withdrawal of a conformity assessment body listed in a Sectoral Annex, a Party shall continue to accept the results of conformity assessment procedures performed by that conformity assessment body prior to withdrawal, unless a Regulatory Authority of the Party decides otherwise based on health, safety and environmental considerations or failure to satisfy other requirements within the scope of the applicable Sectoral Annex. Article 10 MONITORING OF CONFORMITY ASSESSMENT BODIES The following shall apply with regard to the monitoring of conformity assessment bodies listed in a Sectoral Annex: a) Designating Authorities shall assure that their conformity assessment bodies listed in a Sectoral Annex are capable and remain capable of properly assessing conformity of products or processes, as applicable, and as covered in the applicable Sectoral Annex. In this regard, Designating Authorities shall maintain, or cause to maintain, ongoing surveillance over their conformity assessment bodies by means of regular audit or assessment; b) The Parties undertake to compare methods used to verify that the conformity assessment bodies listed in the Sectoral Annexes comply with the relevant requirements of the Sectoral Annexes. Existing systems for the evaluation of conformity assessment bodies may be used as part of such comparison procedures; c) Designating Authorities shall consult as necessary with their counterparts, to ensure the maintenance of confidence in conformity assessment procedures. With the consent of both Parties, this consultation may include joint participation in audits/inspections related to conformity assessment activities or other assessments of conformity assessment bodies listed in a Sectoral Annex; and 23 Initialled on 20 June 1997 d) Designating Authorities shall consult, as necessary, with the relevant Regulatory Authorities of the other Party to ensure that all technical requirements are identified and are satisfactorily addressed. Article 11 CONFORMITY ASSESSMENT BODIES Each Party recognizes that the conformity assessment bodies listed in the Sectoral Annexes fulfill the conditions of eligibility to assess conformity in relation to its requirements as specified in the Sectoral Annexes. The Parties shall specify the scope of the conformity assessment procedures for which such bodies are listed. Article 12 EXCHANGE OF INFORMATION 1. The Parties shall exchange information concerning the implementation of the legislative, regulatory, and administrative provisions identified in the Sectoral Annexes. 2. Each Party shall notify the other Party of legislative, regulatory and administrative changes related to the subject matter of this Agreement at least 60 days before their entry into force. Where considerations of safety, health or environmental protection require more urgent action, a Party shall notify the other Party as soon as practicable. 3. Each Party shall promptly notify the other Party of any changes to its Designating Authorities and/or conformity assessment bodies. 4. The Parties shall exchange information concerning the procedures used to ensure that the listed conformity assessment bodies under their responsibility comply with the legislative, regulatory, and administrative provisions outlined in the Sectoral Annexes. 5. Regulatory Authorities identified in the Sectoral Annexes shall consult as necessary with their counterparts, to ensure the maintenance of confidence in conformity assessment procedures and to ensure that all technical requirements are identified and are satisfactorily addressed. 24 Initialled on 20 June 1997 Article 13 SECTORAL CONTACT POINTS Each Party shall appoint and confirm in writing contact points to be responsible for activities under each Sectoral Annex. Article 14 JOINT COMMITTEE OF THE PARTIES 1. The Parties hereby establish a Joint Committee consisting of representatives of each Party. The Joint Committee shall be responsible for the effective functioning of the Agreement. 2. The Joint Committee may establish Joint Sectoral Committees comprised of appropriate Regulatory Authorities and others deemed necessary. 3. Each Party shall have one vote in the Joint Committee. The Joint Committee shall make its decisions by unanimous consent. The Joint Committee shall determine its own rules and procedures. 4. The Joint Committee may consider any matter relating to the effective functioning of this Agreement. In particular it shall be responsible for: a) listing, suspension, withdrawal and verification of conformity assessment bodies in accordance with this Agreement; b) amending transitional arrangements in Sectoral Annexes; c) resolving any questions relating to the application of this Agreement and its Sectoral Annexes not otherwise resolved in the respective Joint Sectoral Committees; d) providing a forum for discussion of issues that may arise concerning the implementation of this Agreement; e) considering ways to enhance the operation of this Agreement; 0 coordinating the negotiation of additional Sectoral Annexes; and g) considering whether to amend this Agreement or its Sectoral Annexes in accordance with Article 21. 10 25 Initialled on 20 June 1997 5. When a Party introduces new or additional conformity assessment procedures affecting a Sectoral Annex, the Parties shall discuss the matter in the Joint Committee with a view to bringing such new or additional procedures within the scope of this Agreement and the relevant Sectoral Annex. Article 15 PRESERVATION OF REGULATORY AUTHORITY 1. Nothing in this Agreement shall be construed to limit the authority of a Party to determine, through its legislative, regulatory and administrative measures, the level of protection it considers appropriate for safety; for protection of human, animal, or plant life or health; for the environment; for consumers; and otherwise with regard to risks within the scope of the applicable Sectoral Annex. 2. Nothing in this Agreement shall be construed to limit the authority of a Regulatory Authority to take all appropriate and immediate measures whenever it ascertains that a product may: (a) compromise the health or safety of persons in its territory; (b) not meet the legislative, regulatory, or administrative provisions within the scope of the applicable Sectoral Annex; or (c) otherwise fail to satisfy a requirement within the scope of the applicable Sectoral Annex. Such measures may include withdrawing the products from the market, prohibiting their placement on the market, restricting their free movement, initiating a product recall, and preventing the recurrence of such problems, including through a prohibition on imports. If the Regulatory Authority takes such action, it shall inform its counterpart authority and the other Party within fifteen days of taking such action, providing its reasons. Article 16 SUSPENSION OF RECOGNITION OBLIGATIONS Either Party may suspend its obligations under a particular Sectoral Annex, in whole or in part, if: a) a Party suffers a loss of market access for the Party's products within the scope of the Sectoral Annex as a result of the failure of the other Party to fulfill its obligations under the Agreement; b) the adoption of new or additional conformity assessment requirements as referenced in Article 14(5) results in a loss of market access for the Party's products within the scope of the Sectoral Annex because conformity assessment bodies designated by the Party in order to meet such requirements have not been recognized by the Party implementing the requirements; or II 26 Initialled on 20 June 1997 c) the other Party fails to maintain legal and regulatory authorities capable of implementing the provisions of this Agreement. Article 17 CONFIDENTIALITY 1. Each Party agrees to maintain, to the extent required under its laws, the confidentiality of information exchanged under this Agreement. 2. In particular, neither Party shall disclose to the public, nor permit a conformity assessment body to disclose to the public, information exchanged under this Agreement that constitutes trade secrets, confidential commercial or financial information, or information that relates to an ongoing investigation. 3. A Party or a conformity assessment body may, upon exchanging information with the other Party or with a conformity assessment body of the other Party, designate the portions of the information that it considers to be exempt from disclosure. 4. Each Party shall take all precautions reasonably necessary to protect information exchanged under this Agreement from unauthorized disclosure. Article 18 FEES Each Party shall endeavor to ensure that fees imposed for services under this Agreement shall be commensurate with the services provided. Each Party shall ensure that, for the sectors and conformity assessment procedures covered under this Agreement, it shall charge no fees with respect to conformity assessment services provided by the other Party. Article 19 AGREEMENTS WITH OTHER COUNTRIES Except where there is written agreement between the Parties, obligations contained in mutual recognition agreements concluded by either Party with a party not a signatory to this Agreement (a third party) shall have no force and effect with regard to the other Party in terms of acceptance of the results of conformity assessment procedures in the third party. 12 27 Initialled on 20 June 1997 Article 20 TERRITORIAL APPLICATION This Agreement shall apply, on the one hand, to the territories in which the Treaty establishing the European Community is applied, and under the conditions laid down in that Treaty and, on the other hand, to the territory of the United States. Article 21 ENTRY INTO FORCE, AMENDMENT AND TERMINATION 1. This Agreement including its Sectoral Annexes on Telecommunications Equipment, Electromagnetic Compatibility, Electrical Safety, Recreational Craft, Pharmaceutical GMP Inspections, and Medical Devices shall enter into force on the first day of the second month following the date on which the Parties have exchanged letters confirming the completion of their respective procedures for the entry into force of this Agreement. 2. This Agreement including any Sectoral Annex may, through the Joint Committee, be amended in writing by the Parties. The Parties may add a Sectoral Annex upon the exchange of letters. Such Annex shall enter into force 30 days following the date on which the Parties have exchanged letters confirming the completion of their respective procedures for the entry into force of the Sectoral Annex. 3. Either Party may terminate. this Agreement in its entirety or any individual Sectoral Annex thereof by giving the other Party six months notice in writing. In the case of termination of one or more Sectoral Annexes, the Parties will seek to achieve by consensus to amend this Agreement, with a view to preserving the remaining Sectoral Annexes, in accordance with the procedures in this Article. Failing such consensus, the Agreement shall terminate at the end of six months. 4. Following termination of the Agreement in its entirety or any individual Sectoral Annex thereof, a Party shall continue to accept the results of conformity assessment procedures performed by conformity assessment bodies under this Agreement prior to termination, unless a Regulatory Authority in the Party decides otherwise based on health, safety and environmental considerations or failure to satisfy other requirements within the scope of the applicable Sectoral Annex. 13 28 Initialled on 20 June 1997 Article 22 FINAL PROVISIONS 1. The Sectoral Annexes referred to in Article 21. 1, as well as any New Sectoral Annexes added pursuant to Article 21. 2, shall form an integral part of this Agreement. 2. For a given product or sector, the provisions contained in the relevant Sectoral Annexes shall apply in the first place, and the provisions of this text in addition to those provisions. In the case of any inconsistency between the provisions of a Sectoral Annex and this text, the Sectoral Annex shall prevail, to the extent of that inconsistency. 3. This Agreement shall not affect the rights and obligations of the Parties under any other international agreement. 4. In the case of the Sectoral Annex on Medical Devices, the Parties shall review the status of such Annex at the end of three years from entry into force. This Agreement and the Sectoral Annexes are drawn up in two originals in the Danish, Dutch, English, Finnish, French, German, Greek, Italian, Portuguese, Spanish and Swedish languages, each text being equally authentic. In the event of inconsistencies of interpretation, the English text shall be determinative. DONE at this day of , 1997. FOR THE GOVERNMENT OF THE FOR THE EUROPEAN COMMUNITY: UNITED STATES OF AMERICA: 14 29 Initialled on 20 June 1997 US - EC MRA Telecommunication Equipment Annex EC - U. S. MRA SECTORAL ANNEX FOR TELECOMMUNICATION EQUIPMENT PREAMBLE Recognizing that this Annex constitutes a Sectoral Annex to the Agreement on Mutual Recognition of Conformity Assessment between the United States and the European Community, 15 30 Initialled on 20 June 1997 US - EC MRA Telecommunication Equipment Annex SECTION I LEGISLATIVE, REGULATORY AND ADMINISTRATIVE PROVISIONS EC U. S. Communication Act of 1934, as amended by the Telecommunication Act of 1996, (Title 47 of the United States Code), the U. S. regulatory and administrative provisions in respect of telecommunication equipment, including 47 CFR Part 68, and FCC interpretation thereof; (The Parties recognize that the FCC Form 730 Application Guide provides useful guidelines for the implementation of conformity assessment procedures for telecommunication terminal equipment falling within these regulations. ); The U. S. regulatory and administrative provisions in respect of all radio transmitters subject to an equipment authorization requirement. A non-exclusive list of FCC regulations are contained in Section II; For electrical safety, see Electrical Safety Sectoral Annex to the Agreement; For electromagnetic compatibility aspects, see Electromagnetic Compatibility (EMC) Sectoral Annex to the Agreement, Council Directive 91/263/EEC, as supplemented by Council Directive 93/97/EEC and amended by Council Directive 93/68/EEC, and interpretation thereof; (The Parties recognize that the Handbook on the implementation of Directive 91 /263/EEC (ADLNB and ACTE approved), provides useful guidelines for the implementation of conformity assessment procedures falling under this Directive. ); Commission Decisions (CTRs) established under Council Directives 91/263/EEC and •»' 93/97/EEC; The EC Member States' legislation and regulations in respect of: (a) non-harmonized analogue connection to the public telecommunications network*; (b) non-harmonized radio transmitters-for which there is a civilian equipment authorization requirement; * The EC agrees to seek authority to include non-harmonized digital connections; For electrical safety, see Electrical Safety Sectoral Annex to the Agreement; For electromagnetic compatibility aspects, see Electromagnetic Compatibility (EMC) Sectoral Annex to the Agreement. 16 31 Initialled on 20 June 1997 US - EC MRA Telecommunication Equipment Annex SECTION II SCOPE AND COVERAGE This Sectoral Annex shall apply to equipment, interfaces, and services subject to Section I. In general terms the provisions of this Sectoral Annex shall apply to the following types of telecommunications terminal equipment, satellite terminal equipment, technology equipment: transmitters, and information radio (a) equipment intended for connection to the public telecommunications network in order to send, process or receive information, whether the equipment is to be connected directly to the "termination" of the network or to inter-work with such a network, being connected directly or indirectly to the termination point. The system of connection may be wire, radio, optical or other electro-magnetic means; (b) equipment capable of being connected to a public telecommunications network even if it is not its intended purpose, including information technology equipment having a communication port; and (c) all radio transmitters subject to an equipment authorization procedure by either Party. The following is a non-exclusive list of the equipment, interfaces, and services included within the scope of this Sectoral Annex: 17 32 <6 Initialled on 20 June 1997 US - EC MRA Telecommunication Equipment Annex SECTION II (continued) SCOPE AND COVERAGE EC The following equipment categories are included : ISDN Basic Rate Access ISDN Primary Rate Access ISDN Telephony X21/V. 24/V. 35 Access X25 Access PSTN Non-Voice PSTN Voice Band (Analog) ONP Leased Line Terminal types : -64 kbits/sec -2048 kbits/s unstructured -2048 kbits/s structured -34 Mbits/s access -140 Mbits/s access -2 wire analogue -4 wire analogue * Radio transmitters subject to an equipment authorization requirement, including: U S. Equipment categories covered under 47 CFR Part 68, including: ISDN Basic Access ISDN Primary Rate Access Digital Service Access : 2. 4 kbps 3. 2 kbps (2. 4 kbps with Secondary Channel) 4. 8 kbps 6. 4 kbps (4. 8 kbps with SC) 9. 6 kbps 12. 8 kbps (9. 6 kbps with SC) 19. 2 kbps 25. 0 kbps (19. 2 kbps with SC) 56. 0 kbps 64. 0 kbps (uses 72 kbps channel) 72. 0 kbps (56. 0 kbps with SC) 1. 544 Mbps 2 wires analog tie trunks/ops 4 wire analog tie trunks/ops PSTN Voice Band (Analog) Access Private Line (Analog) Access (List to be provided before signing Radio transmitters subject to an equipment of Sectoral Annex. ) (Part 20) (Part 21) (Part 22) authorization requirement, including: Commercial Mobile Radio Domestic Public Fixed Domestic Mobile Personal Communication Service (Part 24) Satellite Communications Broadcast Auxiliary Broadcast Cable Television Radio Maritime GMDSS Private Land Mobile Private-Fixed Microwave Personal Radio Services IVDS Amateur Radio Radio Frequency Devices Fixed Microwave Services (Part 25) (Part 73) (Part 74) (Part 78) (Part 80) (Part 80W) (Part 90) (Part 94) (Part 95) (Part 95 F) (Part 97) (Part 15) (Part 101) Note: A list of acronyms and a glossary is contained in Appendix I to this Sectoral Annex. 18 33 Initialled on 20 June 1997 US - EC MRA Telecommunication Equipment Annex SECTION III CONFORMITY ASSESSMENT PROCEDURES FOR TELECOMMUNICATION EQUIPMENT 1. Description of Mutual Recognition Obligations In accordance with the provisions of the Agreement, the results of the conformity assessment procedures produced by a Party's conformity assessment bodies listed in Section V. shall be recognized by the Regulatory Authorities of the other Party without any further conformity assessment of the products, pursuant to Section I. 2, Conformity Assessment Procedures Taking into account the legislative, regulatory, and administrative provisions as identified in Section I, each Party recognizes that the conformity assessment bodies of the other Party, listed in Section V, are authorized to perform the following procedures with regard to the importing Party's technical requirements for telecommunications terminal equipment, satellite terminal equipment, radio transmitters or information technology equipment: a) b) c) testing and issuing of test reports; issuing certificates of conformity to the requirements of the laws and regulations applicable in the territories of the Parties for products covered under this Sectoral Annex; and performing quality assurance certification pursuant to Council Directive 91/263/EEC. 19 34 Initialled on 20 June 1997 US - EC MRA Telecommunication Equipment Annex SECTION IV AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES LISTED IN SECTION V EC U. S. National Institute of Standards and Technology (NIST) Federal Communications Commission (FCC) Austria: Bundesministerium furWissenschaft,Verkehr und Lumst. Belgium: BIPT. Denmark: Telestyrelsen. Finland: Telecommunications Administration Centre. Germany: Bundesministerium fur Wirtschaft (Bonn) Greece: Ministry of Transport & Communications. France: Direction Generate des Postes & Telecommunications Ireland: Dept. of Transport, Energy & Communications. Italy: Ispettorato General TLC. Luxembourg: Administration des Postes et Telecommunications. Netherlands: Min. Verkeer en Waterstaat, Telecom, en Post Department. Portugal: Instituto das Communicacoes. Spain: Ministerio de Formento Sweden: National Post & Telecom Agency + SWEDAC. UK: I Dept of Trade & Industry. 20 35 Initialled on 20 June 1997 US - EC MRA Telecommunication Equipment Annex SECTION V CONFORMITY ASSESSMENT BODIES EC US; Conformity assessment bodies located in the EC shall be designated by the Authorities identified in Section IV following the procedures set out in Section VI of this Annex. Conformity assessment bodies located in the U. S. shall be designated by the Authorities identified in Section IV following the procedures set out in Section VI of this Annex. (to be provided by the EC upon notification by the Member States). (to be provided by the U. S. ) 21 36 Initialled on 20 June 1997 US - EC MRA Telecommunication Equipment Annex SECTION VI DESIGNATING, LISTING, SUSPENDING, WITHDRAWING AND MONITORING CONFORMITY ASSESSMENT BODIES LISTED IN SECTION V EC U. S. EC Access to U. S. Market: U. S. Access to EC Market: EC Authorities identified in Section IV shall designate conformity assessment bodies located in the EC in accordance with the U. S. legislative, regulatory, and administrative provisions identified in Section I that govern designation of conformity assessment bodies, based on compliance with the appropriate ISO/IEC Guides (e. g. Guide 22, 25, 28, 58, 61, 62, 6J, etc. ) or the comparable EN-45000 Series Standards. U. S. Authorities identified in Section IV shall designate conformity assessment bodies located in the U. S. in accordance with the EC legislative, regulatory, and administrative provisions identified in Section I that govern designation of conformity assessment bodies, based on compliance with the appropriate EN-45000 Series Standards or the comparable ISO/IEC Guides (e. g. Guide 22, 25, 28, 58, 61, 62, 65, etc. ). Procedures for designating, listing, suspending, withdrawing, and monitoring a conformity assessment body listed in Section V shall be undertaken pursuant to Articles 7, 8, 9, and 10 of the Agreement. Procedures for designating, listing, suspending, withdrawing, and monitoring a conformity assessment body listed in Section V shall be undertaken pursuant to Articles 7, 8, 9, and 10 of the Agreement. 37 Initialled on 20 June 1997 US - EC MRA Telecommunication Equipment Annex SECTION VII ADDITIONAL PROVISIONS 1. SUB - CONTRACTING 1. 1 Any sub-contracting by conformity assessment bodies shall be in accordance with the sub-contracting requirements of the other Party. Notwithstanding the use of sub-contracting, the final results of conformity assessment remain the full responsibility of the listed conformity assessment body. In the EC, these requirements are described in Council Decision 93/465/EEC. 1. 2 The conformity assessment bodies shall record and retain details of their investigation of the competence and compliance of their subcontractors and maintain a register of all sub-contracting. These details will be available to the other Party on request. 2. POST-MARKET SURVEILLANCE, BORDER MEASURES AND INTERNAL MOVEMENT 2. 1 For the purpose of post-market surveillance, the Parties may maintain any existing labeling and numbering requirements. The assignment of the numbers may take place in the territory of the exporting Party. The numbers will be allocated by the importing Party. Numbering and labeling systems shall not introduce additional requirements within the meaning of this Sectoral Annex. 2. 2 Nothing in this Sectoral Annex shall prevent the Parties from removing products from the market that do not in fact conform to the requirements for approval. 2. 3 The Parties agree that border inspections and checks of products which have been certified, labeled or marked as conforming with the importing Party's requirements specified in Section I shall be completed as expeditiously as possible. With regard to any inspections related to internal movement within their respective territories, the Parties agree that these shall be completed in no less a favorable manner than for like-domestic goods. 3. JOINT SECTORAL COMMITTEE 3. 1 A combined Joint Sectoral Committee for this Sectoral Annex and the EMC Sectoral Annex is hereby established (the JSC). The JSC shall operate during the transitional period and after completion of the transitional arrangement. The JSC shall meet as appropriate to discuss technical, conformity assessment and technology issues relating to this Sectoral Annex and the EMC Sectoral Annexes. The JSC shall determine its own rules of procedure. 38 Initialled on 20 June 1997 US - EC MRA Telecommunication Equipment Annex 3. 2 The JSC consists of representatives of the U. S. and the EC for telecommunications and EMC. JSC representatives may each invite manufacturers and other entities as deemed necessary. The representatives for the U. S. shall have one vote in the JSC. The representatives of the EC shall have one vote in the JSC. Decisions of the JSC shall be made by unanimous consent. In the event of disagreement either the U. S. or EC representative may raise the matter in the Joint Committee. 3. 3 The JSC may address any matter related to the effective functioning of this Sectoral Annex, including: a) providing a forum for discussion of issues and resolving problems that may arise concerning the implementation of this Sectoral Annex; b) developing a mechanism for ensuring consistency of interpretations of legislation, regulations, standards, and conformity assessment procedures; c) advising the Parties on matters relating to this Sectoral Annex; and d) providing guidance and, if necessary, developing guidelines during the transitional period to facilitate the successful completion of the transitional period. 4. CONTACT POINT Each Party shall establish a contact point to provide answers to all reasonable inquiries from the other Party regarding procedures, regulations, and complaints under this Sectoral Annex. 5. REGULATORY CHANGES AND UPDATING THE SECTORAL ANNEX In the event that there are changes to the legislative, regulatory, and administrative provisions referenced in Section I or the introduction of new legislative, regulatory, and administrative provisions affecting either Party's conformity assessment procedures under the Agreement, such changes shall take effect for the purpose of this Sectoral Annex at the same time they take effect domestically within the territory of each Party. The Parties shall update this Sectoral Annex to reflect the changes. 24 39 Initialled on 20 June 1997 US - EC MRA Telecommunication Equipment Annex SECTION VIII TRANSITIONAL ARRANGEMENT 1. There shall be a transitional period of 24 months. 2. The purpose of this transitional arrangement is to provide a means whereby the Parties to the Agreement can build confidence in and an understanding of each other's system for designating and listing conformity assessment bodies and in the ability of these bodies to test and certify products. Successful completion of the transitional arrangement should result in the determination that conformity assessment bodies listed in Section V comply with the applicable criteria and are competent to conduct conformity assessment activities on behalf of the other Party. Upon successful completion of the transition period, the results of conformity assessment procedures performed by the exporting Party's conformity assessment bodies listed in Section V of the exporting country shall be accepted by the importing Party. 3. This transitional period shall be used by the Parties: a) to consider new legislative changes needed to support the objectives of the Agreement; d) b) to initiate regulatory changes needed to support the objectives of the Agreement; to exchange information on and develop better understanding of their respective c) regulatory requirements; to develop mutually agreed mechanisms for exchanging information on changes in technical requirements or methods of designating conformity assessment bodies; and to monitor and evaluate the performance of the listed conformity assessment bodies during the transitional period. e) 4. Parties may designate, list, suspend and withdraw conformity assessment bodies during the transitional period according to the procedures in Section VI of this Sectoral Annex. 5. During the transitional period each Party shall accept and evaluate test reports and related documents issued by designated conformity assessment bodies of the other Party. To this end, the Parties shall ensure that: a) on receipt of test reports, related documents and a first evaluation of conformity, the dossiers are promptly examined for completeness; the applicant is informed in a precise and complete manner of any deficiency; b) c) any request for additional information is limited to omissions, inconsistencies or variances from the technical regulations or standards; and d) procedures for assessing the conformity for equipment modified subsequent to a determination of compliance, are limited to procedures necessary to determine continued conformance. 6. Each Party ensures that issuance of approvals, certificates, or advice to the applicant shall be given no later than six weeks from receipt of the test report and evaluation from a designated conformity assessment body in the territory of the other Party. 25 40 Initialled on 20 June 1997 US - EC MRA Telecommunication Equipment Annex 7. Any proposal made during or at the end of the transitional period to limit the scope of recognition of any designated conformity assessment body or to exclude it from the list of bodies designated under this Sectoral Annex shall be based on objective criteria and documented. Any such body may apply for reconsideration once the necessary corrective action has been taken. To the extent possible, the Parties shall implement such action prior to the expiry of the transitional period. 8. The Parties may jointly sponsor two seminars, one in the U. S. and one in the European Community, concerning the relevant technical and product approval requirements during the first year after this Sectoral Annex enters into force. 9. Passage from the transitional phase into the operational phase in this Sectoral Annex shall take place provided that a representative number of conformity assessment bodies have been accepted for recognition under the Electrical Safety Annex. 26 41 Initialled on 20 June 1997 US - EC MRA Telecommunication Equipment Annex APPENDIX 1 LISTS OF ACRONYMS AND GLOSSARY Approvals Committee for Terminal Equipment ACTE ADLNB Association of Designated Laboratories and Notified Bodies CAB CFR CTR EC EEC EN EU FCC IEC ISDN ISO ITU MRA MS NB NIST OJ ONP PSTN STG TBR X21 X25 Conformity Assessment Body U. S. Code of Federal Regulations, Title 47 CFR Common Technical Regulation European Community European Economic Community Norme Européenne (European Standard) European Union Federal Communications Commission International Electrotechnical Commission Integrated Services Digital Network International Standards Organization International Telecommunications Union Mutual Recognition Agreement Member States (of the European Union) Notified Bodies National Institute of Standards and Technology Official Journal (of the European Union) Open Network Provision Public Switched Telephone Network Sectoral Technical Group for Telecommunications Technical Basis for Regulation ITU-T Recommendation X21 ITU-T Recommendation X25 40 Initialled on 20 June 1997 US - EC MRA Electromagnetic Compatibility Annex EU - U. S. MRA SECTORAL ANNEX FOR ELECTROMAGNETIC COMPATIBILITY (EMC) PREAMBLE Recognizing that this Annex constitutes a Sectoral Annex to the framework Agreement on Mutual Recognition of Conformity Assessment between the United States and the European Community. 29 43 initialled on 20 June 1997 US - EC MRA Electromagnetic Compatibility Annex SECTION I LEGISLATIVE, REGULATORY AND ADMINISTRATIVE PROVISIONS EC U. S. Council Directive 89/336/EEC, as amended by Council Directives 91/263/EEC, 92/31/EEC, interpretation 93/68/EEC and 93/97/EEC and thereof. For electrical safety aspects see Electrical Safety Sectoral Annex to the Agreement. telecommunication equipment and radio also Telecommunications For transmitters, Equipment Sectoral Annex to the Agreement. see of Communications Act as amended by -the Telecommunication Act of 1996, (Title 47 of the United States Code), 1934. the U. S. regulatory and administrative provisions in respect of equipment subject to requirements including: electromagnetic - 4 7 C F R P a r t l5 - 4 7 C F R P a r t l 8, and FCC interpretation thereof. For electrical -safety aspects see Electrical Safety Sectoral Annex to the Agreement. For telecommunication equipment and radio also Telecommunications Equipment Sectoral Annex to the Agreement. transmitters, see SECTION II SCOPE AND COVERAGE EC US. For US access to the EU market: For EU access to the US market: Any product falling under the scope of Any products falling under the scope of Council Directive 89/336/EEC. 47 CFR Part 15 and 18. 30 44 Initialled on 20 June 1997 US - EC MRA Electromagnetic Compatibility Annex SECTION III CONFORMITY ASSESSMENT PROCEDURES FOR EQUIPMENT IDENTIFIED IN SECTION II 1. Description of Mutual Recognition Obligations In accordance with the provisions of the Agreement, the results of the conformity assessment procedures produced by a Party's conformity assessment bodies listed in Section V, shall be recognized by the Regulatory Authorities of the other Party without any further conformity assessment of the products, pursuant to Section I. 2. Conformity Assessment Procedures Taking into account the legislative, regulatory, and administrative provisions as identified in Section I, each Party recognizes that the conformity assessment bodies of the other Party, listed in Section V, are authorized to perform the following procedures with regard to the importing Party's technical requirements for equipment identified in Section II: a) testing and issuing of test reports; b) issuing certificates of conformity to the requirements of the laws and regulations applicable in the territories of the Parties for products covered under this Sectoral Annex. 31 45 Initialled on 20 June 1997 US - EC MRA Electromagnetic Compatibility Annex SECTION IV AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES LISTED IN SECTION V EU Ujj. Austria: Bundesministerium fur wirtschaftliche Angelegenheiten National Institute of Standards and Technology (NIST) Federal Communications Commission (FCC) Federal Aviation Administration (FA A) Abteilung Belgium: Denmark: Finland: France: Germany: Greece: Ireland: Italy: Luxemburg: Netherlands: Portugal: Spain: Sweden: U. K. : (list to be completed later) 46 Initialled on 20 June 1997 US - EC MRA Electromagnetic Compatibility Annex SECTION V CONFORMITY ASSESSMENT BODIES EC ILS. For EC access to the U. S. market: For U. S. access to the EC market: Conformity assessment bodies located in Conformity assessment bodies located in the U. S. shall be designated by the the EC shall be designated by the Authorities in Section IV following the procedures set out in following Section VI of this Annex. Section VI of this Annex. in Section IV Authorities identified the procedures set out in identified (to be provided by the EC) (to be provided by the U. S. ) 33 47 Initialled on 20 June 1997 US - EC MRA Electromagnetic Compatibility Annex SECTION VI DESIGNATING, LISTING, SUSPENDING, WITHDRAWING AND MONITORING CONFORMITY ASSESSMENT BODIES LISTED IN SECTION V EC Access to U. S. Market: U. S. Access to EC Market: EC U. S. legislative, EC Authorities identified in Section IV shall designate conformity assessment bodes located in the EC in accordance with regulatory^ and the U. S. administrative provisions in identified Section I that govern designation of conformity assessment bodies, based upon compliance with the appropriate ISO/IEC Guides (e. g. Guide 22, 25, 28, 58, 61, 62, 65, etc. ) or the comparable EN-45000 Series Standards. U. S. Authorities identified in Section IV shall designate conformity assessment bodies located in the U. S. in accordance with the EC legislative, regulatory, and administrative provisions in Section I that govern designation of conformity assessment bodies, based on compliance with the appropriate EN-45000 Series Standards or the comparable ISO/IEC Guides (e. g. Guide 22, 25, 28, 58, 61, 62, 65, etc. ). identified for designating, Procedures listing, suspending, withdrawing, and monitoring a conformity assessment body in Section V shall be undertaken pursuant to Articles 7, 8, 9, and 10 of the Agreement. listed for designating, Procedures listing, suspending, withdrawing, and monitoring a conformity assessment body in Section V shall be undertaken pursuant to Articles 7, 8, 9, and 10 of the Agreement. listed 34 48 Initialled on 20 June 1997 US - EC MRA Electromagnetic Compatibility Annex SECTION VII ADDITIONAL PROVISIONS 1. SUB - CONTRACTING 1. 1 Any sub-contracting by conformity assessment bodies shall be in accordance with the sub-contracting requirements of the other Party. Notwithstanding the use of sub-contracting, the final results of conformity assessment remain the full responsibility of the listed conformity assessment body. In the EC, these requirements are described in Council Decision 93/465/EEC. 1. 2 The conformity assessment bodies shall record and retain details of its investigation of the competence and compliance of its subcontractors and maintain a register of ail sub-contracting. These details will be available to the other Party on request. 2. POST-MARKET SURVEILLANCE, BORDER MEASURES AND INTERNAL MOVEMENT 2. 1 For the purpose of post-market surveillance, the Parties may maintain any existing labeling and numbering requirements. The assignment of the numbers may take place in the territory of the exporting Party. The numbers will be allocated by the importing Party. Numbering and labeling systems shall not introduce additional requirements within the meaning of this Sectoral Annex. 2. 2 Nothing in this Sectoral Annex shall prevent the Parties from removing products from the market that do not in fact conform to the requirements for approval. 2. 3 The Parties agree that border inspections and checks of products which have been certified, labeled or marked as conforming with the importing Party's requirements specified in Section I shall be completed as expeditiously as possible. With regard to any inspections related to internal movement within their respective territories, the Parties agree that these shall be completed in no less a favorable manner than for like-domestic goods. 3. JOINT SECTORAL COMMITTEE 3. 1 A combined Joint Sectoral Committee for this Sectoral Annex and the Telecommunications Equipment Sectoral Annex is hereby established (the JSC). The JSC shall operate during the transitional period and after completion of the transitional arrangement. The JSC shall meet as appropriate to discuss technical, conformity assessment and technology issues relating to this Sectoral Annex and the Telecommunications Equipment Sectoral Annex. The JSC shall determine its own rules of procedure. 35 49 Initialled on 20 June 1997 US - EC MRA Electromagnetic Compatibility Annex 3. 2 The JSC consists of representatives of the U. S. and the EC for telecommunications and EMC. JSC representatives may each invite manufacturers and other entities as deemed necessary. The representatives for the U. S. shall have one vote in the JSC. The representatives of the EC shall have one vote in the JSC. Decisions of the JSC shall be made by unanimous consent. In the event of disagreement either the U. S. or EC representatives may raise the matter in the Joint Committee. 3. 3 The JSC may address any matter related to the effective functioning of this Sectoral Annex, including : a) b) c) d) providing a forum for discussion of issues and resolving problems that may arise concerning the implementation of this Sectoral Annex; developing a mechanism for ensuring consistency of interpretations of legislation, regulations, standards, and conformity assessment procedures. advising the Parties on matters relating to this Sectoral Annex; providing guidance and, if necessary, developing guidelines during the transitional period to facilitate the successful completion of the transitional period. 4. CONTACT POINT Each Party shall establish a contact point to provide answers to all reasonable inquiries from the other Party regarding procedures, regulations and complaints under this Sectoral Annex. 5. REGULATORY CHANGES AND UPDATING THE SECTORAL ANNEX In the event that there are changes to the legislative, regulatory and administrative provisions referenced in Section I or the introduction of new legislative, regulatory and administrative provisions affecting either Party's conformity assessment procedures under the Agreement, such changes shall take effect for the purpose of this Sectoral Annex at the same time they take effect domestically within the territory of each Party. The Parties shall update this Sectoral Annex to reflect the changes. 36 50 Initialled on 20 June 1997 US - EC MRA Electromagnetic Compatibility Annex SECTION VIII TRANSITIONAL ARRANGEMENT 1. There shall be a transitional period of 24 months. 2. The purpose of this transitional arrangement is to provide a means whereby the Parties to the Agreement can build confidence in and understanding of each others system for designating and listing conformity assessment bodies and in the ability of these bodies to test and certify products. Successful completion of the transition arrangement should result in the determination that conformity assessment bodies listed in Section V comply with the applicable criteria and are competent to conduct conformity assessment activities on behalf of the other Party. Upon completion of the transition period, the results of conformity assessment procedures performed by the exporting Party's conformity assessment bodies listed in Section V shall be accepted by the importing Party. 3. This transitional period shall be used by the Parties : a) to consider new legislative changes needed to support the objectives of the Agreement; b) to initiate regulatory changes needed to support the objectives of the Agreement; c) to exchange information on and develop better understanding of their respective regulatory requirements; d) to develop mutually agreed mechanisms for exchanging information on changes in technical requirements or methods of designating conformity assessment bodies; and e) to monitor and evaluate the performance of the listed conformity assessment bodies during the transitional period. 4. Parties may designate, list, suspend and withdraw conformity assessment bodies during the transitional period according to the procedures in Section VI of this Sectoral Annex. 5. During the transitional period each Party shall accept and evaluate test reports and related documents issued by designated conformity assessment bodies of the other Party. To this end, the Parties shall ensure that: - on receipt of test reports, related documents and a first evaluation of conformity, the dossiers are promptly examined for completeness; the applicant is informed in a precise and complete manner of any deficiency; - - any request for additional information is limited to omissions, inconsistencies or variances from the technical regulations or standards; - procedures for assessing the conformity for equipment modified subsequent to a determination of compliance, are limited to procedures necessary to determine continued conformance; 37 ^ — Initialled on 20 June 1997 US - EC MRA Electromagnetic Compatib ility Annex 6. Each Party ensures that issuance of approvals, certificates or advice to the applicant shall be given no later than six weeks from receipt of the test report and evaluation from a designated conformity assessment body in the territory of the other Party. 7. Any proposal made during or at the end of the transitional period to limit the scope of recognition of any designated conformity assessment body or to exclude it from the list of bodies designated under this Sectoral Annex shall be based on objective criteria and documented. Any such body may apply for reconsideration once the necessary corrective action has been taken. To the extent possible, the Parties shall implement such action prior to the expiry of the transitional period. 8. The Parties may jointly sponsor two seminars, one in U. S. and one in the European Community, concerning the relevant technical and product approval requirements during the first year after this Sectoral Annex enters into force. 9. Passage from the transitional phase into the operational phase in this Sectoral Annex shall take place provided that a representative number of conformity assessment bodies have been accepted for recognition under the Electrical Safety Annex. O fa Initialled on 20 June 1997 US - EC MRA Electrical Safety Annex EC-U. S. MRA SECTORAL ANNEX FOR ELECTRICAL SAFETY PREAMBLE Recognizing that this Annex constitutes a Sectoral Annex to the Agreement on Mutual Recognition between the United States and the European Community. 39 53 Initialled on 20 June 1997 US - EC MRA Electrical Safety Annex SECTION I LEGISLATIVE REGULATORY AND ADMINISTRATIVE PROVISIONS EC IXS. For U. S. access to the EC market: For EC access to the U. S. market Council Directive 73/23/EEC of 19 February 1973 as amended by 93/68/EEC. 29 U. S. C. 651 et seq. U. S. 29 CFR 1910. 7 Products that are certified or approved under the Federal Mine Safety and Health Act (30 U. S. C. 801 fiLsegJ or its regulations and used in areas under the authority of the Mine Safety and Health Administration, are not covered under this Annex. OSHA will consider regulatory and legislative changes needed to support the objectives of the MRA. For medical devices, see the Medical Devices Sectoral Annex to this Agreement. For medical devices, see the Medical Devices Sectoral Annex to this Agreement. For electromagnetic compatibility aspects, see the For electromagnetic compatibility aspects. Electromagnetic Compatibility (EMC) Sectoral Annex to this Agreement. see the Electromagnetic Compatibility (EMC) Sectoral Annex to this Agreement. For telecommunications equipment, see the Telecommunications Equipment Sectoral Annex to this Agreement. For telecommunications equipment, see the Telecommunications Equipment Sectoral Annex to this Agreement. 40 54 Initialled on 20 June 1997 US - EC MRA Electrical Safety Annex SECTION II SCOPE AND COVERAGE EC U. S. For U. S. access to the EC market: For EC access to the U. S. market: The electrical safety requirements of products The electrical safety requirements of products falling under the scope of 29 falling under the scope of Council Directive 73/23/EEC on the harmonization of the laws CFR 1910 subpart S. This includes the electrical safety aspects for workplace of the Member States relating to electrical ' safety of medical equipment and equipment designed for use within certain telecommunication terminal equipment voltage limits. within the scope of those Sectoral Annexes. Products that are certified or approved under the Federal Mine Safety and Health Act (30 U. S. C. 801 et seq. ^ or its regulations and used in areas under the authority of the Mine Safety and Health Administration, are not covered under this Annex. 41 55 Initialled on 20 June 1997 US - EC MRA Electrical Safety Annex SECTION III DESCRIPTION OF MUTUAL RECOGNITION OBLIGATIONS In accordance with the provisions of the Agreement, EC conformity assessment bodies listed in Section V of this Annex shall be recognized to test, certify and mark products within the scope of their NRTL recognition for assessing conformity to U. S. requirements. With regard to U. S. conformity assessment bodies listed in Section V of this Annex, in the event of a challenge within the European Community under Article 8. 2 of Council Directive 73/23/EEC of 19 February 1973, test reports issued by such conformity assessment bodies shall be accepted by the European Community Authorities in the same way that reports from European Community Notified Bodies are accepted. That is, (listed conformity assessment bodies) in the U. S. shall be recognized under Article 11 of Council Directive 73/23/EEC as "bodies which may make a report in accordance with Article 8. " 42 56 Initialled on 20 June 1997 US - EC MRA Electrical Safety Annex SECTION IV AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES LISTED IN SECTION V U. S. For U. S. access to the EC market: National Institute for Standards and Technology (NIST) EC For EC access to the U. S. Market: Member States Authorities: Austria: ' Belgium: Danmark: Finland: France: - Germany: Greece: Ireland: Italy: Luxembourg: Netherlands: Portugal: Spain: Sweden: U. K. Bundesministerium fur wirtschaftiche Angelegenheiten Ministere des Affaires Economiques / Ministerie van Economische Zaken Elektricitetsraadet Ministry of Trade and Industry Ministere de l'^conomie, des finances et de 1'Industrie Bundesmin. fur Arbeit und Sozialordnung Ministry of Development Department of EnterpriseTrade and Employment Ministero dell' Industria Service de l'Energie de l'Etat Min van Economische Zaken Istituto Portugues da Qualidade Ministerio de Industria y Energia Styrelsen for Ackreditering och Teknisk Kontroll Department of Trade & Industry 43 57 Initialled on 20 June 1997 US - EC MRA Electrical Safety Annex SECTION V CONFORMITY ASSESSMENT BODIES EC U. S. For EC access to the U. S. market: For U. S. access to the EC market: The names and scope of responsibilities of Conformity Assessment Bodies located in the EC and listed in accordance with this Sectoral Annex: The names and scope of responsibilities of Conformity Assessment Bodies located in the U. S. and listed in accordance with this Sectoral Annex: [** An initial list of Conformity Assessment Bodies should be listed in this Section by the time we implement the Agreement. **] 44 58 Initialled on 20 June 1997 US - EC MRA Electrical Safety Annex SECTION VI DESIGNATING. LISTING. SUSPENDING AND WITHDRAWING CONFORMITY ASSESSMENT BODIES EC U. S. For EC access to the US. market: For U. S. access to the EC market: Conformity assessment bodies from the EC shall be designated by the EC Authorities identified in Section the Joint Committee, in accordance with the recognition procedures in the Agreement and this Annex. IV and recognized by Conformance with the appropriate ISO/IEC Guides or the corresponding EN 4500 series of standards shall be deemed consistent with U. S. requirements identified in Section I. For purposes of designation and listing, EC Designating Authorities identified in Section IV shall designate conformity assessment bodies located in the EC by filing a properly prepared proposal for listing, which includes a complete lab assessment under the U. S. OSHA procedures. OSHA shall notify the EC Designating Authority normally within 30 days as to whether the proposal is complete or whether additional information is required. rely on OSHA shall the. EC Designating Authorities identified in Section IV for conducting on-site reviews at the respective Member States' conformity assessment bodies. Conformity assessment bodies from the U. S. shall be designated by the U. S. Authority identified in Section IV and recognized by the Joint Committee, in recognition accordance with procedures in the Agreement and Council Directive 73/23/EEC. the series of Conformance with the appropriate EN 4500 the corresponding ISO/IEC Guides shall be deemed consistent with the requirements of Council Directive 73/23/EEC. standards or For purposes of designating and listing, the U. S. Designating Authority identified in Section IV shall designate conformity assessment bodies located in the U. S. by filing a properly prepared proposal for listing with the EC, which includes a the complete following EC or Member State procedures, as appropriate: lab assessment under The EC shall notify the U. S. Designating Authority within 30 days as to whether the proposal is complete and shall indicate, additional any where information that is required. applicable, 45 59 Initialled on 20 June 1997 US - EC MRA Electrical Safety Annex SFCT1QN VI f continued^ EC U. S. Upon receipt of a complete proposal, the U. S. exercising its authority under its law shall: in operational phase Equipment (a) prior to the passage from the transitional phase the into the Telecommunications and (EMC) Sectoral Electromagnetic Compatibility Annexes, give notice of its consent or objection to a proposed conformity assessment body to the Joint Committee. The listing of an agreed conformity assessment body in Section V of this Sectoral Annex shall only occur upon such passage from the transitional phase into the operational phase of those Sectoral Annexes. Upon receipt of a complete proposal, the EC shall give notice of consent or objection to the Joint Committee within 60 days. The Joint Committee shall monitor the recognition of conformity assessment bodies and confirm such a recognition by listing them in Section V of this Sectoral Annex. The U. S. conformity assessment bodies listed in Section V shall have Notified Body status within the EC. in the operational phase Equipment (b) subsequent to passage from the transitional the into phase Telecommunications and Electromagnetic Compatibility (EMC) Sectoral Annexes, give notice of its consent or objection to a proposed conformity assessment body to the Joint Committee normally within 120 business days. The listing of an agreed conformity assessment body in Section V of this Sectoral Annex shall occur upon notice of consent to the Joint Committee and the Joint Committee's decision to list such body. listing procedures shall supersede These the procedures in Article 7(c) of the Agreement in its entirety and the time periods set out in Article 7(d) of the Agreement. EC conformity assessment bodies listed in Section V shall have NRTL status in the U. S. 46 80 Initialled on 20 June 1997 US - EC MRA Electrical Safety Annex SECTION VI (continued^! EC U. S. With regard to the suspension of a conformity assessment body listed in this Sectoral Annex, the period specified in Article 8(e) of the Agreement shall begin to run after a Party has notified the Joint Sectoral Committee or the Joint Committee, pursuant to Article 8(c) of the Agreement, that it proposes to revoke the conformity assessment body's its in accordance with procedures under its applicable domestic law. recognition Except as provided for in this Section, procedures for designation, listing, suspension and withdrawal of conformity assessment bodies under this Sectoral Annex shall be carried out in accordance with Articles 7, 8 and 9 of the Agreement. 47 61 Initialled on 20 June 1997 US - EC MRA Electrical Safety Annex SECTION VII JOINT SECTORAL COMMITTEE FOR ELECTRICAL SAFETY The Joint Sectoral Committee for Electrical Safety (JCS/ES) consists of representatives of the U. S. and the EC. ÔSHA shall represent the U. S. on this Joint Sectoral Committee. The EC and OSHA may invite the participation of others as deemed necessary. Each Party shall have one vote and decisions shall be made by unanimous consent, unless otherwise specified herein. The Joint Sectoral Committee shall determine its own rules of procedure. The Joint Sectoral Committee may address any matter related to the effective functioning of this Sectoral Annex, including : - Developing improved procedures and criteria for designation in order to facilitate the assessment and preparation of proposals by Designating Authorities, with a view towards expediting the period between designation and listing; - providing a forum for discussion of issues that may arise concerning the implementation of this Sectoral Annex; - advising the Parties on matters relating to this Sectoral Annex; and - enhancing the operation of this Sectoral Annex. 48 62 Initialled on 20 June 1997 US - EC MRA Recreational Craft Annex EC - U. S. MRA SECTORAL ANNEX FOR RECREATIONAL CRAFT This Annex constitutes a Sectoral Annex to the Agreement on Mutual Recognition between the Unites States and the European Community. The purpose of this Sectoral Annex is to establish a framework to accept certificates of conformity issued in the territory of one Party in accordance with the regulatory requirements of the other Party as referenced in this Sectoral Annex. To facilitate that purpose, a transitional period of eighteen months is arranged to build confidence as defined in this Sectoral Annex, Section 6. 49 63 Initialled on 20 June 1997 US - EC MRA Recreational Craft Annex 1. 2. 1. 2. SECTION 1 LEGISLATIVE. REGULATORY. AND ADMINISTRATIVE REQUIREMENTS For the European Community: European Parliament and European Council Directive 94/25 EEC on the Approximation of the Laws, Regulations, and Administrative Provisions of the Member States Relating to Recreational Craft. For the US,: 46 U. S. C. Chapter 43, 33 CFR 81, 84, 159, 179, 181,183 and 46 CFR 58. SECTION 2 SCOPE AND COVERAGE This Sectoral Annex applies to all recreational craft which in the European Community or the United States are subject to conformity assessment by a conformity assessment body or an approval procedure, as applicable, before being put on the market. The product coverage for each Party shall be determined by the following relevant requirements: (a) for the European Community: Recreational craft as defined in Directive 94/25 EEC. (b) for the United States: Any product falling under the scope of 46 U. S. C. Chapter 43, 33 CFR 81, 84, 159, 179, 181, 183 and 46 CFR 58. 50 64 Initialled on 20 June 1997 US - EC MRA Recreational Craft Annex The Parties agree that for mutual recognition to operate under this Sectoral Annex, the following arrangements shall apply: (a) (b) for approvals to European Community requirements, conformity assessment bodies designated by the U. S. shall establish compliance as required to be demonstrated by Directive 94/25 EEC. This demonstration of compliance shall be recognized in the European Community and products so certified shall have unrestricted access to the EC market for sale as recreational craft, pursuant to Section 1. for approvals to United States requirements, conformity assessment bodies designated by the European Community shall establish compliance as required to be demonstrated as set forth in paragraph 2(b) of this Section and products so certified shall have unrestricted access to the U. S. market for sale as recreational craft, pursuant to Section 1. SECTION 3 AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES 1. For the European Community: Member States Administrations as indicated in the Directive 94/25 EEC, Article 9. 1. 2. For the United States: National Institute of Standards and Technology (NI ST). 51 65 Initialled on 20 June 1997 US - EC MRA Recreational Craft Annex SECTION 4 DESIGNATING. LISTING. SUSPENDING AND WITHDRAWING CONFORMITY ASSESSMENT BODIES 1. For the purpose of this Sectoral Annex, each party shall designate competent conformity assessment bodies to carry out conformity assessment and approval to the requirements of the other Party. Such designation shall be carried out according to the procedures set out in Article 7 of the Agreement. A list of conformity assessment bodies together with the products and procedures for which they have been listed, is in Section 5 below. 2. Each Party agrees that the listed conformity assessment bodies comply with the requirements for such bodies established by the other Party. These are: (a) (b) for the European Community, bodies which are Notified Bodies in accordance with Directive 94/25 EEC, are deemed to be in compliance with U. S. requirements; for the U. S. , in accordance with the requirements set out in the regulations listed in Section 1, the conformity assessment bodies listed in Section 5 are designated by NIST using the evaluation procedures contained in the appropriate EN 45000 series of standards or the corresponding ISO/IEC Guides. 3. With regard to the designation, listing, suspension and withdrawal of conformity assessment bodies under this Sectoral Annex, the specific procedures in Articles 7, 8 and 9 of the Agreement shall be followed. SECTIONS CONFORMITY ASSESSMENT BODIES European Community The conformity assessment bodies designated by the European Community are those Notified Bodies which have been notified by the Member States of the Community, in accordance with Directive 94/25 EEC, and whose names and reference numbers have been published in the Official Journal of the European Communities. 52 66 Initialled on 20 June 1997 US - EC MRA Recreational Craft Annex 2. United States [To be provided by U. S. ] 1. 2. SECTION 6 TRANSITIONAL ARRANGEMENT There shall be a transitional period of 18 months prior to the operations of this Sectoral Annex. The purpose of the transitional arrangement is to provide a means whereby the Parties to this Agreement can cooperate to establish a system for designating conformity assessment bodies and can mutually build confidence in the this abilities of transitional arrangement that conformity assessment bodies comply with the applicable criteria and to have the equipment approved by the conformity assessment bodies of the exporting country accepted by the approval authority of the importing country Successful completion of in a determination these bodies. is intended to result 3. During this transitional period, the parties shall: (a) exchange information on technical data and conformity assessment criteria and procedures, thus developing greater familiarity with their respective regulatory requirements; and (b) carry out or recommend any applicable policy, regulatory changes necessary for the provisions of this Annex. legislative and Product Scope All products covered by Section 2 of this Annex. Cooperation During this transitional period, both Parties shall endeavor to jointly sponsor seminars for the purpose of improving the understanding of technical specifications applicable in each Party's jurisdiction. Inspections Inspections or audits shall be permitted to verify compliance of conformity assessment bodies with their responsibilities under this Agreement. The scope of these inspections or audits shall be agreed upon in advance by both Parties. 4. 5. 6. 53 67 Initialled on 20 June 1997 US - EC MRA Recreational Craft Annex SECTION 7 ADDITIONAL PROVISIONS 1. 2. In accordance with the relevant provisions of the Agreement, the Parties shall ensure the continued availability of the names of their respective notified bodies or conformity assessment bodies, and shall regularly supply details of certifications issued in order to facilitate post market surveillance. The Parties note that, to the extent that requirements for electrical safety or electromagnetic compatibility may apply to products covered by this Sectoral Annex, the provisions of the Sectoral Annexes on Electrical Safety and Electromagnetic Compatibility apply. SECTION 8 DEFINITIONS Notified Body means a third party authorized to perform the conformity assessment tasks specified in Directive 94/25 EEC, which has been appointed by a Member State from the bodies falling within its jurisdiction. The Notified Body has the necessary qualifications to meet requirements laid down in Directive 94/25 EEC and has been notified to the Commission and to the other Member States. 54 68 Initialled on 20 June 1997 US - EC MRA Pharmaceutical Good Manufacturing Practices Annex EC-U. S. MRA SECTORAL ANNEX FOR PHARMACEUTICAL GOOD MANUFACTURING PRACTICES (GMPs) PREAMBLE Recognizing that this Annex constitutes a Sectoral Annex to the framework Agreement on Mutual Recognition between the United States and the European Community. 55 69 Initialled on 20 June 1997 US - EC MRA Pharmaceutical Good Manufacturing Practices Annex CHAPTER 1 DEFINITIONS, PURPOSE, SCOPE AND COVERAGE Article 1 Definitions 1. "Equivalence " of the regulatory systems means that the systems are sufficiently comparable to assure that the process of inspection and the ensuing inspection reports will provide adequate information to determine whether respective statutory and regulatory requirements of the authorities have been fulfilled. "Equivalence" does not require that the respective regulatory systems have identical procedures. 2. "Enforcement" means action taken by an authority to protect the public from products of suspect quality, safety and efficacy or to assure that products are manufactured in compliance with appropriate laws, regulations, standards and commitments made as part of the approval to market a product. 3. "Good Manufacturing Practices " ^tentative merging of US and EC concepts to be revisited) GMPs mean the requirements found in the respective legislations, regulations, and administrative provisions for methods to be used in, and the facilities or controls to be used for, the manufacturing, processing, packing, and/or holding of a drug to assure that such drug meets the requirements as to safety, and' has the identity and strength, and meets the quality and purity characteristics that it purports or is represented to process. GMPs are that part of quality assurance which ensures that products are consistently produced and controlled to quality standards. For the purpose of this Annex, GMPs include therefore the system whereby the manufacturer receives the specifications of the product and/or process from the Marketing Authorization/Product Authorization or License holder or applicant and ensures the product is made in compliance with its specifications (Qualified Person certification in the EC). 4. "Inspection" means an on-site evaluation of a manufacturing facility to determine whether such manufacturing facility is operating in compliance with Good Manufacturing Practices and/or commitments made as part of the approval to market a product. 5. "Inspection Report" means the written observations and Good Manufacturing in Practices compliance assessment completed by an authority Appendix 2. listed 6. "Regulatory System" means the body of legal requirements for Good Manufacturing Practices, inspections, and enforcements that ensure public health protection and legal authority to assure adherence to these requirements. 56 70 Initialled on 20 June 1997 US - EC MRA Pharmaceutical Good Manufacturing Practices Annex Article 2 Purpose The provisions of this Annex govern the exchange between the Parties and normal endorsement by the receiving authority of official Good Manufacturing Practices (GMP) inspection reports after a transitional period aimed at determination of the equivalence of the regulatory systems of the Parties, which is the cornerstone of this Annex. Article 3 Scope The provisions of this Annex shall apply to pharmaceutical inspections carried out in the United States and Member States of the European Community before products are marketed (hereafter referred to as "pre-approval inspections") as well as during their marketing (hereafter referred to as "post-approval inspections"). Appendix 1 names the laws, regulations and administrative provisions governing these inspections and the GMP requirements. Appendix 2 lists the authorities participating in activities under this Annex. Articles 6, 7, 8, 9, 10 and 11 of the Agreement do not apply to this Annex. Article 4 Product coverage These provisions will apply to medicinal products for human or animal use, intermediates and starting materials (as referred to in the EU) and to drugs for human or animal use, biological products for human use, and active pharmaceutical ingredients (as referred to in the United States), only to the extent they are regulated by the authorities of both Parties as listed in Appendix 2. Human blood, human plasma, human tissues and organs, and veterinary immunologicals are excluded from the scope of this Annex. Human plasma derivatives (such as immunoglobulins and albumin), investigational medicinal products/new drugs, human radiopharmaceuticals and medicinal gases are also excluded during the transition phase, their situation will be reconsidered at the end of the transition period. Products regulated by the Center for Biologies Evaluation and Research as devices are not covered under this Annex. Appendix 3 contains an indicative list of products covered by this Annex. 57 71 Initialled on 20 June 1997 US - EC MRA Pharmaceutical Good Manufacturing Practices Annex CHAPTER 2 TRANSITION PERIOD Article 5 Length of transition period A three-year transition period will start immediately after the effective date of the Agreement. Article 6 Equivalence assessment 1. The criteria to be used by the Parties to assess equivalence are listed in the criteria under Community Appendix 4. Information pertaining competence will be provided by the Community. to 2. The authorities of the parties will establish and communicate to each other their draft programs for assessing the equivalence of the respective regulatory systems in terms of quality assurance of the products and consumer protection. These programs will be carried out, as deemed necessary by the authorities, for post- and pre-approval inspections and for various product classes or processes. 3. The equivalence assessment shall include information exchanges (including inspection reports), joint training, and joint inspections for the purpose of assessing regulatory systems and the authorities' capabilities. In conducting the equivalence assessment, the Parties will ensure that efforts are made to save resources. 4. Equivalence assessment for authorities added to Appendix 2 after the effective date of this agreement will be conducted as described in this Annex, as soon as practicable. Article 7 Participation in the equivalence assessment and determination The authorities listed in Appendix 2 will actively participate in these programs to build a sufficient body of evidence for their equivalence determination. Both parties will exercise good to complete equivalence assessment as expeditiously as possible to the extent the resources of the authorities allow. faith efforts Article 8 Other transition activities As soon as possible, the authorities will jointly determine the essential information which must be present in inspection reports and will cooperate to develop mutually agreed inspection report format(s). 58 72 Initialled on 20 June 1997 US - EC MRA Pharmaceutical Good Manufacturing Practices Annex CHAPTER 3 END OF TRANSITION PERIOD Article 9 Equivalence determination Equivalence is established by having in place regulatory systems covering the criteria referred to in Appendix 4, and a demonstrated pattern of consistent performance in accordance with these criteria. A list of authorities determined as equivalent shall be agreed to by the Joint Sectoral Committee at the end of the transition period, with reference to any limitation in terms of inspection type (e. g. post-approval or pre-approval) or product classes or processes. The Parties will document insufficient evidence of equivalence, lack of opportunity to assess equivalence or a determination of non-equivalence, in sufficient detail to allow the authority being assessed to know how to attain equivalence. Article 10 Authorities not listed as currently equivalent Authorities not currently listed as equivalent, or not equivalent for certain types of inspections, product classes or processes may apply for reconsideration of their status once the necessary corrective measures have been taken or additional experience is gained. CHAPTER 4 OPERATIONAL PERIOD Article 11 Start of the operational period The operational period shall start at the end of the transition period and its provisions apply to inspection reports generated by authorities listed as equivalent for the inspections performed in their territory. In addition, when an authority is not listed as equivalent based on adequate experience gained during the transition period, the FDA will accept for normal endorsement (as provided in Article 12) inspection reports generated as a result of inspections conducted jointly by that authority on its territory and another authority listed as equivalent, provided that the authority of the Member State in which the inspection is performed can guarantee enforcement of the findings of the inspection report and require that corrective measures be taken when necessary. FDA has the option to participate in these inspections, and based on experience gained during the transition period, the Parties will agree on procedures for exercising this option. 59 73 Initialled on 20 June 1997 US - EC MRA Pharmaceutical Good Manufacturing Practices Annex In the EC, the qualified person will be relieved of responsibility for carrying the controls laid down in Article 22 paragraph 1(b) of Council Directive 75/319/EEC provided that these controls have been carried out in the United States and that each batch/lot is accompanied by a batch certificate (in accordance with the WHO certification scheme on the quality of medicinal products) the manufacturer certifying that the product complies with requirements of the marketing authorization and signed by the person responsible for releasing the batch/lot. issued by Article 12 Nature of recognition of inspection reports Inspection reports (containing information as established under Article 8), including a GMP compliance assessment, prepared by authorities listed as equivalent, will be provided to the authority of the importing Party. Based on the determination of equivalence in light of the experience gained, these inspection reports will normally be endorsed by the authority of the importing Party, except under specific and delineated circumstances. Examples of such circumstances include indications of material inconsistencies or inadequacies in an inspection report, quality defects identified in the post-market surveillance or other specific evidence of serious concern in relation to product quality or. consumer safety. In such cases, the authority of the importing Party may request clarification from the authority of the exporting Party which may lead to a request for re-inspection. The authorities will endeavor to respond to requests for clarification in a timely manner. Where divergence is not clarified in this process, an authority of the importing country may carry out an inspection of the production facility. Article 13 Transmission of post-approval inspection reports Post-approval GMP inspection reports concerning products covered by this Annex will be transmitted to the authority of the importing country within 60 calendar days of the request. Should a new inspection be needed, the inspection report will be transmitted 90 calendar days of the request. 60 74 Initialled on 20 June 1997 US - EC MRA Pharmaceutical Good Manufacturing Practices Annex Article 14 Transmission ofpre-approval inspection reports A preliminary notification that an inspection may have to take place will be made as soon as possible. Within 15 calendar days, the relevant authority will acknowledge receipt of the request and confirm its ability to carry out the inspection. In the EC, requests will be sent directly to the relevant authority, with a copy to the European Agency for the Evaluation of Medicinal Products (EMEA). If the authority receiving the request cannot carry out the inspection as requested, the requesting authority shall have the right to conduct the inspection. Reports of pre-approval inspections will be sent within 45 calendar days of the request that transmitted the appropriate information and detailed the precise issues to be addressed during the inspection. A shorter time may be necessary in exceptional cases and these will be described in the request. Article 15 Monitoring continued equivalence Monitoring activities for the purpose of maintaining equivalence shall include review of the exchange of inspection reports and their quality and timeliness; performance of a limited number of joint inspections; and the conduct of common training sessions. Article 16 Suspension Each Party has the right to contest the equivalence of an authority. This right will be exercised in an objective and reasoned manner in writing to the other Party. The issue shall be discussed in the Joint Sectoral Committee promptly upon such notification. Where the JSC determines that verification of equivalence is required, it may be carried out jointly by the Parties in a timely manner, pursuant to Article 6. Efforts will be made by the Joint Sectoral Committee to reach unanimous consent on the appropriate action. If agreement to suspend is reached in the Joint Sectoral Committee, an authority may be suspended immediately thereafter. If no agreement is reached in the Joint Sectoral Committee, the matter is referred to the Joint Committee. If no unanimous consent is reached within 30 days after such notification, the contested authority will be suspended. Upon the suspension of an authority previously listed as equivalent, a Party is no longer obligated to normally endorse the inspection reports of the suspended authority. A Party shall continue to normally endorse the inspection reports of that authority prior to suspension, unless the authority of the receiving party decides otherwise based on health or safety considerations. The suspension will remain in effect until unanimous consent has been reached by the Parties on the future status of that authority. 61 75 Initialled on 20 June 1997 US - EC MRA Pharmaceutical Good Manufacturing Practices Annex CHAPTERS JOINT SECTORAL COMMITTEE Article 17 Role and composition of the Joint Sectoral Committee A Joint Sectoral Committee is set up to monitor the activities under both the transitional and operational phases of this Annex. The Committee will be co-chaired by a representative of FDA for the US and a representative of the EC who each will have one vote. Decisions will be taken by unanimous consent. The Joint Sectoral Committee's functions will include: 1. making a joint assessment, which must be agreed by both Parties, of the equivalence of the respective authorities, 2. developing and maintaining the list of equivalent authorities, including any limitation in terms of inspecting type or products, and communicating the list to all authorities and the Joint Committee, 3. providing a forum to discuss issues relating to this Annex, including concerns that an authority may be no longer equivalent and opportunity to review product coverage, 4. consideration of the issue of suspension. The Joint Sectoral Committee shall meet at the request of either Party and, unless the co-chairs otherwise agree, at least once each year. The Joint Committee will be kept informed of the agenda and conclusions of meetings of the Joint Sectoral Committee. CHAPTER 6 INFORMATION EXCHANGE Article 18 Regulatory collaboration The Parties and authorities shall inform and consult one another, as permitted by law, on proposals to introduce new controls or to change existing technical regulations or inspection procedures and to provide the opportunity to comment on such proposals. The Parties shall notify each other in writing of any changes to Appendix 2. 62 76 Initialled on 20 June 1997 US - EC MRA Pharmaceutical Good Manufacturing Practices Annex Articled Information relating to quality aspects The authorities will establish an appropriate means of exchanging information on any confirmed problem reports, corrective actions, recalls, rejected import consignments and other regulatory and enforcement problems for products subject to this Annex. Article 20 Alert System The details of an alert system will be developed during the transitional period. The system will be maintained in place at all times. Elements to be considered in developing such a system are described in Appendix 5. Contact points will be agreed between both Parties to permit authorities to be made aware with the appropriate speed in case of quality defect, recalls, counterfeiting and other problems concerning quality, which could necessitate additional controls or suspension of the distribution of the product. CHAPTER 7 SAFEGUARD CLAUSE Article 21 Each Party recognizes that the importing country has a right to fulfill its legal responsibilities by taking actions necessary to ensure the protection of human and animal health at the level of protection it deems appropriate. This includes the suspension of the distribution, product detention at the border of the importing country, withdrawal of the batches and any request for additional information or inspection as provided in Article 12. 63 77 Initialled on 20 June 1997 US - EC MRA Pharmaceutical Good Manufacturing Practices Annex APPENDIX 1 List of applicable laws, regulations and administrative provisions For the European Community: Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products as extended, widened and amended. Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products as extended, widened and amended. Council Directive 81/851/EEC of 6 November 1981 on the approximation of the laws of the Member States relating to veterinary medicinal products as widened and amended. Commission Directive 91/356/EEC of 13 June 1991 laying down the principles and guidelines of good manufacturing practice for medicinal products for human use Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products Council Regulation No (EEC) 2309/93 of 23 July 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products Council Directive 25/92/EEC of 31 March 1992 on the wholesale distribution of medicinal products for human use & Guide to Good Distribution Practice Current version of the Guide to Good Manufacturing Practice, Rules Governing Medicinal Products in the European Community, Volume IV. For the United States : Relevant sections of the United States Federal Food, Drug, and Cosmetic Act and the United States Public Health Service Act Relevant sections of Title 21, United States Code of Federal Regulations (CFR) Parts 1-99, Parts 200-299, Parts 500-599, and Parts 600-799 Relevant sections of the FDA Investigations Operations Manual, the FDA Regulatory Procedures Manual, the FDA Compliance Policy Guidance Manual, the FDA Compliance Program Guidance Manual, and other FDA guidances. 64 7 8 Initialled on 20 June 1997 US - EC MRA Pharmaceutical Good Manufacturing Practices Annex APPENDIX 2 list of Authorities United States In the United States, the regulatory authority is the Food and Drug Administration. European Community In the European Community, the regulatory authorities are the following: Austria: Belgium: Denmark: Finland: France: Germany: Greece: Ireland: Italy: Bundesministerium fur Arbeit, Gesundheit und Soziales, Wien Ministerie van Sociale Zaken, Volksgezondheid en Leefmilieu/Ministère des Affaires Sociales, Santé Publique et Environnement/Algemene Farmaceutische Inspectie, Inspection Générale de la Pharmacie, Brussel, Bruxelles Lasgemiddelstyrelsen, Danish Medicines Agency, Bronshoj Lââkelaitos/Lâkemedelsverket (National Agency for Medicines), Helsinki Agence du Médicament, Direction de l'inspection et des établissements, Saint Denis (Human) Agence Nationale du Médicament Vétérinaire, Fougères (Veterinary) Bundesgesundheitsministerium, Bonn Paul-Ehrlich Institut, Langen (biologicals only) Zustandige Behôrden der 16 Bundeslânder: Bayern, Berlin, Brandenburg, Bremen, Hamburg, Hessen, Niedersachsen, Nordrhein- Westfalen, Rheinland-Pfalz, Mecklenburg-Vorpommern, Saarland, Sachsen, Sachsenanhalt, Schleswig-Holstein, Thuringen Ministry of Health and Welfare, National Drug Organisation (E. O. F. ), Athens Irish Medicines Board, Dublin Ministero délia Sanità, Dipartimento Farmaci e Farmacovigilanza, Roma - (Human) Ministero délia Sanità, Dipartimento alimenti e nutrizione e sanità pubblica veterinaria - Div. IX, Roma - (Veterinary) Luxembourg: Direction de la Santé, Division de la Pharmacie et des Médicaments, Luxembourg The Netherlands: Staatstoezicht op de Volksgezondheid, Inspectie voor de Gezondheidszorg, Rijswijk Portugal: Spain: Instituto da Farmàcia e do Medicamento (INFARMED), Lisboa Ministerio Sanidad y Consumo, Subdirecciôn. General de Control Farmacéutico, Madrid (Human) Ministerio de Agricultura Pesca y Alimentaciôn, Madrid, (Veterinary) Sweden: Lâkemedelsverket ( Medical Products Agency), Uppsala United Kingdom: Medicines Control Agency, London Veterinary Medicines Directorate, Addlestone European Union: European Commission, Brussels European Agency for the Evaluation of Medicinal Products (EMEA) 65 79 Initialled on 20 June 1997 US - EC MRA Pharmaceutical Good Manufacturing Practices Annex APPENDIX 3 Indicative list of Products covered by the Sectoral Annex Recognizing that precise definition of medicinal products and drugs are to be found in the legislations referred to above, an indicative list of products covered by the agreement is given below: - human medicinal products including prescription and non-prescription drugs; - human biologicals including vaccines, and immunologicals; - veterinary pharmaceuticals, including prescription and non-prescription drugs, with the exclusion of veterinary immunologicals; - pre-mixes for the preparation of veterinary medicated feeds (EC), Type A - medicated articles for the preparation of veterinary medicated feeds (US); intermediate products and active pharmaceutical pharmaceuticals (US) / starting materials (EC). ingredients or bulk 66 30 Initialled on 20 June 1997 US - EC MRA Pharmaceutical Good Manufacturing Practices Annex APPENDIX 4 Criteria for Assessing Equivalence for Post- and Pre-Approval I. Legal / Regulatory authority and structures and procedures providing for post- and pre-approval: A. Appropriate statutory mandate and jurisdiction. B. Ability to issue and update binding requirements on GMPs and guidance documents. C. Authority to make inspections, review and copy documents, and to take samples and collect other evidence. D. Ability to enforce requirements and to remove products found in violation of such requirements from the market. E. Substantive current good manufacturing requirements F. Accountability of the regulatory authority. G. Inventory of current products and manufacturers. H. System for maintaining or accessing inspection reports, samples and other analytical data, and other firm/product information relating to matters covered by this Sectoral Annex. II. Mechanisms in place to assure appropriate professional standards and avoidance of conflicts of interest. III. Administration of the regulatory authority: A. Standards of education/qualification and training. B. Effective quality assurance systems measures to ensure adequate job performance. C. Appropriate staffing and resources to enforce laws and regulations. IV. Conduct of Inspections: A. Adequate preinspection preparation, including appropriate expertise of investigator / team, review of firm / product and databases, and availability of appropriate inspection equipment. 67 81 Initialled on 20 June 1997 US - EC MRA Pharmaceutical Good Manufacturing Practices Annex B. Adequate conduct of inspection, including statutory access to facilities, effective response to refusals, depth and competence of evaluation of operations, systems, and documentation; collection of evidence; appropriate duration of inspection and completeness of written report of observations to firm management. C. Adequate post-inspection activities, including completeness of inspectors' report, inspection report review where appropriate, and conduct of follow- up inspections and other activities where appropriate, assurance of preservation and retrieval of records. V. Execution of regulatory enforcement actions to achieve corrections, designed to prevent future violations, and to remove products found in violation of requirements from the market. VI. Effective Use of Surveillance Systems: A. Sampling and analysis B. Recall monitoring C. Product defect reporting system D. Routine surveillance inspections E. Verification of approved manufacturing process changes to marketing authorizations / approved applications VII. Additional specific criteria for pre-approval inspections A. Satisfactory demonstration through a jointly developed and administered inspections to assess the authorities' training program and joint capabilities. B. Pre-inspection preparation includes the review of appropriate records, including site plans and drug master file or similar documentation to enable adequate inspections. C. Ability to verify chemistry, manufacturing and control data supporting an application is authentic and complete. D. Ability to assess and evaluate research and development data as scientifically sound, especially transfer technology of pilot, scale up and full scale production batches. E. Ability to verify conformity of the on site processes and procedures with those described in the application. F. Review and evaluate equipment installation, operational and performance qualification data, and evaluate test method validation. 68 O fa Initialled on 20 June 1997 US - EC MRA Pharmaceutical Good Manufacturing Practices Annex APPENDIX 5 Elements to be Considered in Developing a Two-wav Alert System 1. Documentation - Definition of a crisis/emergency and under what circumstances an alert is required - Standard Operating Procedures (SOPs) - Mechanism of health hazards evaluation and classification - Language of communication and transmission of information 2. Crisis Management System - Crisis analysis and communication mechanisms - Establishment of contact points - Reporting mechanisms «. 3. Enforcement Procedures - Follow-up mechanisms - Corrective action procedures 4. Quality Assurance System - Pharmacovigilance programme - Surveillance/monitoring of implementation of corrective action 5. Contact points For the purpose of this agreement, the contact points for the alert system will be: for the European Community, the Executive Director of the European Agency for the Evaluation of Medicinal Products, 7, Westferry Circus, Canary Wharf, UK - London El4 4HB, England. Telephone +44-171-418 8400, Fax 418 8416. for the United States: O O Initialled on 20 June 1997 US - EC MRA Medical Devices Annex EU - U. S. MRA SECTORAL ANNEX ON MEDICAL DEVICES PREAMBLE Recognizing that this Annex constitutes a Sectoral Annex to the Agreement on Mutual Recognition in Relation to Conformity Assessment (Agreement) between the United States (U. S. ) and the European Community (EC), Acknowledging that carrying out the provisions of this Annex will further public health protection, will be an important means of facilitating commerce in medical devices, and will lead to reduced costs for regulators and manufacturers of both Parties, The Parties agree as follows: 71 84 Initialled on 20 June 1997 US - EC MRA Medical Devices Annex CHAPTER 1 PURPOSE, SCOPE AND COVERAGE OF THE SECTORAL ANNEX Article 1 Purpose 1. The purpose of this Annex is to specify the conditions under which a Party will accept the results of quality system-related evaluations and inspections and premarket evaluations of the other Party with regard to medical devices as conducted by listed conformity assessment bodies (CABs) and to provide for other related cooperative activities. 2. This Annex is intended to evolve as programs and policies of the Parties evolve. The Parties will review this Annex periodically, in order to assess progress and identify potential enhancements to this Annex as FDA and EC policies evolve over time. Article 2 Scope 1. The provisions of this Annex shall apply to the exchange and, where appropriate, endorsement of the following types of reports from CABs assessed to be equivalent: a. Under the U. S. system, surveillance/post-market and initial/pre-approval inspection reports; b. Under the U. S. system, premarket (510(k)) product evaluation reports; c. Under the EC system, quality system evaluation reports; and d. Under the EC system, EC type examination and verification reports. Appendix 1 names the legislation, regulations, and related procedures under which: (a) products are regulated as medical devices by each Party; (b) CABs are designated and confirmed; and (c) these reports are prepared. 2. For purposes of this Annex, equivalence means that: CABs in the EC are capable of conducting product and quality systems evaluations against U. S. regulatory requirements in a manner equivalent to those conducted by FDA; and CABs in the U. S. are capable of conducting product and quality systems evaluations against EC regulatory requirements in a manner equivalent to those conducted by EC CABs. 72 O D Initialled on 20 June 1997 US - EC MRA Medical Devices Annex Article 3 Product Coverage There are three components to this agreement each covering a discrete range of products: 1. Quality System Evaluations - U. S. -type surveillance/post-market and initial/pre-approval inspection reports and EC-type quality system evaluation reports will be exchanged with regard to all products regulated under both U. S. and EC law as medical devices. 2. Product Evaluation - U. S. -type premarket (510(k)) product evaluation reports and EC- type-testing reports will be exchanged only with regard to those products classified under the U. S. system as Class I/CIass II - Tier 2 medical devices which are listed in Appendix 2. 3. Post-Market Vigilance Reports - Post-market vigilance reports will be exchanged with regard to all products regulated under both U. S. and EC law as medical devices. Additional products and procedures may be made subject to this Annex by agreement of the Parties. > Article 4 Regulatory A uthorities The regulatory authorities shall have the responsibility of implementing the provisions of this Annex, including the designation and monitoring of CABs. Regulatory authorities are specified in Appendix 3. Each Party will promptly notify the other Party in writing of any change in the regulatory authority for a country. CHAPTER 2 TRANSITION PERIOD Article 5 Length and purpose of transition period There will be a three-year transition period immediately following the date of entry into force of the Agreement. During the transition period, the Parties will engage in confidence-building activities for the purpose of obtaining sufficient evidence to make determinations concerning the equivalence of CABs of the other Party with respect to the ability to perform quality system and product evaluations or other reviews resulting in reports to be exchanged under this Annex. 73 86 Initialled on 20 June 1997 US - EC MRA Medical Devices Annex Article 6 Listing of CABs Each Party shall designate CABs to participate in confidence-building activities by transmitting to the other Party a list of CABs which meet the criteria for technical competence and independence, as identified in Appendix 1. The list shall be accompanied by supporting evidence. Designated CABs will be listed in Appendix 4 for participation in the confidence building activities once confirmed by the importing Party. Non-confirmation would have to be justified based on documented evidence. Article 7 Confidence Building Activities 1. At the beginning of the transitional period, the Joint Sectoral Group will establish a joint confidence building program calculated to provide sufficient evidence of the capabilities of the designated CABs to perform quality system or product evaluations to the specifications of the Parties. 2. The joint confidence building program should include the following actions and activities: a. Seminars designed to inform the Parties and CABs about each Party ' s regulatory system, procedures, and requirements; b. Workshops designed to provide the Parties with information regarding requirements and procedures for the designation and surveillance of CABs; c. Exchange of information about reports prepared during the transition period; d. Joint training exercises; and e. Observed inspections. 3. During the transition period, any significant problem that is identified with a CAB may be the subject of cooperative activities, as resources allow and as agreed to by the regulatory authorities, aimed at resolving the problem. 4. Both Parties will exercise good faith efforts to complete the confidence building activities as expeditiously as possible to the extent that the resources of the Parties allow. 5. Both the EC and the U. S. will each prepare annual progress reports which will describe the confidence building activities undertaken during each year of the transition period. The form and content of the reports will be determined by the Parties through the Joint Sectoral Committee. 74 87 Initialled on 20 June 1997 US - EC MRA Medical Devices Annex Article 8 Other transition period activities 1. During the transition period, the Parties will jointly determine the necessary information which must be present in quality system and product evaluation reports. 2. The Parties will jointly develop a notification and alert system to be used in case of defects, recalls, and other problems concerning product quality that could necessitate additional actions (e. g. , inspections by the Parties of the importing. country) or suspension of the distribution of the product. CHAPTER 3 END OF TRANSITION PERIOD Article 9 Equivalence Assessment 1. In the final six months of the transition period, the Parties shall proceed to a joint assessment of the equivalence of the CABs that participated in the confidence building activities. CABs will be determined to be equivalent provided they have demonstrated proficiency through the submission of a sufficient number of adequate reports. CABs may be determined to be equivalent with regard to the ability to perform any type of quality system or product evaluation covered by this Annex and with regard to any type of product covered by this Annex. The parties shall develop a list contained in Appendix 5 of CABs determined to be equivalent which shall contain a full explanation of the scope of the equivalency determination, including any appropriate limitations, with regard to performing any type of quality system or product evaluation. 2. The Parties shall allow CABs not listed for participation in the MRA, or listed for participation only as to certain types of evaluations, to apply for participation in this MRA once the necessary measures have been taken or sufficient experience has been gained, in accordance with Article 18. 3. Decisions concerning the equivalence of CABs must be agreed to by both Parties. 75 § § Initialled on 20 June 1997 US - EC MRA Medical Devices Annex CHAPTER 4 OPERATIONAL PERIOD Article 10 Start of the operational period 1. The operational period will start at the end of the transition period after the Parties have developed the list of CABs found to be equivalent. The provisions of this Chapter will apply only with regard to listed CABs and only to the extent of any specifications and limitations contained on the list with regard to a CAB. 2. The operational period will apply to quality system evaluation reports and product evaluation reports generated by CABs listed in accordance with this Annex for the evaluations performed in the respective territories of the Parties, except if the Parties agree otherwise. Exchange and endorsement of quality system evaluation reports Article 11 1. Listed EC CABs will provide FDA with reports of quality system evaluations, as follows: a. For pre-approval quality system evaluations, EC CABs will provide full répons; and b. For surveillance quality system evaluations, EC CABs will provide abbreviated reports. 2. Listed U. S. CABs will provide to the EC Notified Body of the manufacturer's choice: a. Full reports of initial quality system evaluations; b. Abbreviated reports of quality systems surveillance audits. 3. If the abbreviated reports do not provide sufficient information, the importing Party may request additional clarification from the CAB. 76 8 9 Initialled on 20 June 1997 US - EC MRA Medical Devices Annex Based on the determination of equivalence in light of the experience gained, the quality system evaluation reports prepared by the CABs listed as equivalent will normally be endorsed by the importing Party, except under specific and delineated circumstances. Examples of such circumstances include indications of material inconsistencies or inadequacies in a report, quality defects identified in post-market surveillance or other specific evidence of serious concern in relation to product quality or consumer safety. In such cases, the importing Party may request clarification from the exporting Party which may lead to a request for re-inspection. The Parties will endeavor to respond to requests for clarification in a timely manner. Where divergence is not clarified in this process, the importing Party may carry out the quality system evaluation. Article 12 Exchange and endorsement of product evaluation reports 1. EC CABs listed for this purpose will, subject to the specifications and limitations on the list, provide to the FDA 510(k) premarket notification assessment reports prepared to U. S. medical device requirements. 2. U. S. CABs will, subject to the specifications and limitations on the list, provide to the EC notified body of the manufacturer's choice, type examination and verification reports prepared to EC medical device requirements. 3. Based on the determination of equivalence in light of the experience gained, the product evaluation reports prepared by the CABs listed as equivalent will normally be endorsed by the importing Party, except under specific and delineated circumstances. Examples of such circumstances include indications of material inconsistencies, inadequacies, or incompleteness in a product evaluation report, or to product safety, other specific evidence of serious concern performance, or quality. In such cases, the importing Party may request clarification from the exporting Party which may lead to a request for a re- evaluation. The parties will endeavor to respond to requests for clarification in a timely manner. Endorsement remains the responsibility of the importing Party. in relation Article 13 Transmission of quality system evaluation reports Quality system evaluation reports covered by Article 11 concerning products covered by this Annex shall be transmitted to the importing Party within 60 calendar days of a request by the importing Party. Should a new inspection be requested the time period shall be extended by an additional 30 calendar days. A Party may request a new If the exporting Party cannot inspection, for cause, perform an inspection within a specified period of time, the importing Party may perform an inspection on its own. identified to the other Party. 77 9 0 Initialled on 20 June 1997 US - EC MRA Medical Devices Annex Article 14 Transmission of product evaluation reports Transmission of product evaluation reports will take place according to the importing Party ' s specified procedures. Article 15 Monitoring continued equivalence Monitoring activities will be carried out in accordance with Article 10 of the Agreement. Article 16 Listing of Additional CABs 1. During the operational phase, additional CABs will be considered for equivalence using the procedures and criteria described in Articles 6, 7, and 9 of this Annex, taking into account the level of confidence gained in the overall regulatory system of the other Party. 2. Once a designating authority considers that such CABs, having undergone the procedures of Articles 6, 7, and 9 of this Annex, may be determined to be equivalent, it will then designate those bodies on an annual basis. Such procedures satisfy the procedures of Article 7(a) and (b) of the Agreement. 3. Following such annual designations, the procedures for confirmation of CABs under Articles 7(c) and (d) of the Agreement shall apply. CHAPTER 5 JOINT SECTORAL COMMITTEE Article 17 Role and composition of the Joint Sectoral Committee 1. A Joint Sectoral Management Committee is set up to monitor the activities under both the transitional and operational phases of this Annex. 2. The Committee will be co-chaired by a representative of the FDA for the U. S. and a representative of the EC who will each have one vote. Decisions will be taken by unanimous consent. 78 Q1 Initialled on 20 June 1997 US - EC MRA Medical Devices Annex 3. The JSC's functions will include: a. making a joint assessment of the equivalence of CABs; b. developing and maintaining the list of equivalent CABs, including any limitation in terms of their scope of activities and communicating the list to all authorities arid the Joint Committee; c. providing a forum to discuss issues relating to this Annex, including concerns that a CAB may no longer be equivalent and opportunity to review product coverage; and d. consideration of the issue of suspension. CHAPTER 6 HARMONIZATION AND INFORMATION EXCHANGE Article 18 Harmonization During both the transitional and operational phases of this Agreement, both Parties intend to continue to participate in the activities of the Global Harmonization Task Force and utilize the results of those activities to the extent possible. Such participation involves developing and reviewing documents developed by the Global Harmonization Task Force and jointly determining whether they are applicable to the implementation of this Agreement. Article 19 Regulatory cooperation The Parties and authorities shall inform and consult with one another, as permitted by law, of proposals to introduce new controls or to change existing technical regulations or inspection procedures and to provide the opportunity to comment on such proposals. The Parties shall notify each other in writing of any changes to Appendix 1. 79 92 Initialled on 20 June 1997 US - EC MRA Medical Devices Annex Alert system and exchange of post-market vigilance reports Article 20 1. An alert system will be set up during the transition period and maintained thereafter by which the Parties will notify each other when there is an immediate danger to public health. Elements of such a system will be described in an Appendix to be attached to this Sectoral Annex. As part of that system, each Party shall notify the other Party of any confirmed problem reports, corrective actions, or recalls. These reports are regarded as part of ongoing investigations. 2. Contact points will be agreed between both Parties to permit authorities to be made aware with the appropriate speed in case of quality defect, batch recalls, counterfeiting and other problems concerning quality, which could necessitate additional controls or suspension of the distribution of the product. 80 9 3 Initialled on 20 June 1997 US - EC MRA Medical Devices Annex APPENDIX 1 RELEVANT LEGISLATION, REGULATIONS AND PROCEDURES 1. For the European Union the following legislation applies to Article 2 paragraph 1 : a. Council Directive 90/385/EEC of 20 June 1990 on active implantable medical devices - OJ No. L 189, 20. 7. 1990, p. 17. Conformity assessment procedures. * Annex 2 (with the exception of section 4) *Annex 4 *Annex 5 b. Council Directive 93/42/EEC of 14 June 1993 on Medical Devices OJ No. L 169,12. 7. 1993, p. l. Conformity assessment procedures. * Annex 2 (with the exception of section 4) *Annex 3 *Annex 4 *Annex 5 *Annex 6 2. For the United States, the following legislation applies to Article 2 paragraph 1 : a. The Federal Food, Drug and Cosmetic Act, 21 U. S. C. §§ 321 et seq. b. The Public Health Service Act, 42 U. S. C. §§ 201 et seq. c. Regulations of the United States Food and Drug Administration found at 21 C. F. R. , in particular, Parts 800 to 1299. d. Medical Devices; Third-Party Review of Selected Premarket Notifications; Pilot Program, 61 Fed. Reg. 14,789-14,796 (April 3, 1996). 81 94 Initialled on 20 June 1997 US - EC MRA Medical Devices Annex APPENDIX 2 SCOPE OF PRODUCT COVERAGE 1. Initial Coverage of the Transition Period Upon entry into force of this Annex,1 products qualifying for the transitional arrangements under this Agreement include: a. All Class I products requiring premarket evaluations in the United States - see Table 1. b. Those Class II products listed in Table 2. 2. During the Transition Period: The Parties will jointly identify additional product groups, including their related accessories, in line with their respective priorities as follows: a. Those for which review may be based primarily on written guidance which the Parties will use their best efforts to prepare expeditiously; and b. Those for which review may be based primarily on international standards, in order for the Parties to gain the requisite experience. The corresponding additional product lists will be phased in on an annual basis. The Parties may consult with industry and other interested Parties in determining which products will be added. 3. Commencement of the Operational Period: a. At the commencement of the operational period, product coverage shall extend to all Class I/II products covered during the transition period. b. FDA will expand the program to categories of Class II devices as is consistent with the results of the pilot, and with the FDA's ability to write guidance documents if the device pilot for the third party review of medical devices is successful. The MRA will cover to the maximum extent feasible all Class II devices listed in Table 3 for which FDA-accredited third-party review is available in the U. S. 4. Unless explicitly included by joint decision of the Parties, this agreement does not cover any U. S. Class II -tier 3 or any Class III product under either system. 1 It is understood that the date of entry into force will not occur prior to June 1, 1998, unless the Parties decide otherwise. 95 Initialled on 20 June 1997 US-EC MRA Medical Devices Annex TABLE 1 CLASS I PRODUCTS REQUIRING PREMARKET EVALUATIONS IN THE UNITED STATES, INCLUDED IN SCOPE OF PRODUCT COVERAGE AT BEGINNING OF TRANSITION PERIOD TABLE 1: CLASS I PRODUCTS REQUIRING PREMARKET EVALUATIONS IN THE UNITED STATES ANESTHESIOLOGY PANEL (868) Section No. ************ * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * ** * * * * * * * * * * * * * ** Regulation Name Product Code - Device Name 868. 1910 868. 5620 868. 5640 868. 5675 868. 5700 868. 6810 ESOPHAGEAL STETHOSCOPE BZW - STETHOSCOPE, ESOPHAGEAL. BREATHING MOUTHPIECE BYP - MOUTHPIECE, BREATHING MEDICINAL NONVENTILATORY NEBULIZER (ATOMIZER) CCQ - NEBULIZER, MEDICINAL, NON VENTILATORY (ATOMIZER) REBREATHING DEVICE BYW - DEVICE, REBREATHING NONPOWERED OXYGEN TENT FOG - HOOD, OXYGEN, INFANT BYL - TENT, OXYGEN TRACHEOBRONCHIAL SUCTION CATHETER BSY - CATHETERS, SUCTION, TRACHEOBRONCHIAL 83 Q g Initialled on 20 June 1997 US - EC MRA Medical Devices Annex CARDIOVASCULAR PANEL Regulation Name Product Code - Device Name Section No. ************ a******************************************************************* * * * * * * * * * * * * * ** (NONE) DENTAL PANEL (872) Section No. ************ * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * ** Regulation Name Product Code - Device Name * * * * * * * * * * * * * ** 872. 3400 872. 3700 872. 4200 KARAYA AND SODIUM BORATE WITH OR WITHOUT ACACIA DENTURE ADHESIVE KOM - ADHESIVE, DENTURE, ACACIA AND KARAYA WITH SODIUM BORATE DENTAL MERCURY (U. S. P) ELY - MERCURY DENTAL HANDPIECES AND ACCESSORIES EBW - CONTROLLER, FOOD, HANDPIECE AND CORD EFB - HANDPIECE, AIR-POWERED, DENTAL EFA - HANDPIECE, BELT AND/OR GEAR DRIVEN, DENTAL EGS - HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL EKX - HANDPIECE, DIRECT DRIVE, AC-POWERED EKY - HANDPIECE, WATER-POWERED 872. 6640 DENTAL OPERATIVE UNIT EIA - UNIT, OPERATIVE DENTAL 84 97 Initialled on 20 June 1997 US - EC MRA Medical Devices Annex EAR, NOSE, AND THROAT PANEL (874) Section No. ************ * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * ** * * * * * * * * * * * * * ** Regulation Name Product Code - Device Name 874. 1070 874. 1500 874. 1800 874. 1925 874. 3300 874. 4100 874. 5300 874. 5550 874. 5840 SHORT INCREMENT SENSITIVITY INDEX (SISI) ADAPTER ETR - ADAPTER, SHORT INCREMENT SENSITIVITY INDEX (SISI) GUSTOMETER ETM - GUSTOMETER AIR OR WATER CALORIC STIMULATOR KHH - STIMULATOR, CALORIC-AIR ETP - STIMULATOR, CALORIC-WATER TOYNBEE DIAGNOSTIC TUBE ETK - TUBE, TOYNBEE DIAGNOSTIC HEARING AID LRB - FACE PLATE HEARING-AID ESD - HEARING-AID, AIR-CONDUCTION EPISTAXIS BALLOON EMX - BALLOON, EPISTAXIS ENT EXAMINATION AND TREATMENT UNIT ETF - UNIT, EXAMINING/TREATMENT, ENT POWERED NASAL IRRIGATOR KMA - IRRIGATOR, POWERED NASAL ANTISTAMMERING DEVICE KTH - DEVICE, ANTI-STAMMERING 85 98 Initialled on 20 Jtfne 1997 US-EC MRA Medical Devices Annex GASTROENTEROLOGY - UROLOGY PANEL (876) Regulation Name Product Code - Device Name Section No. ************ * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * ** * * * * * * * * * * * * * ** 876. 5160 ^ UROLOGICAL CLAMPS FOR MALES 876. 5210 876. 5250 EXTERNAL USE FHA - CLAMP, PENILE ENEMA KIT FCE - KIT, ENEMA, (FOR CLEANING PURPOSE) URINE COLLECTOR AND ACCESSORIES FAQ - BAG, URINE COLLECTION, LEG, FOR GENERAL HOSPITAL PANEL (880) Section No. ************ * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * ** * * * * * * * * * * * * * ** Regulation Name Product Code - Device Name 880. 5270 880. 5420 880. 5680 880. 6250 NEONATAL EYE PAD FOK - PAD, NEONATAL EYE PRESSURE INFUSOR FOR I. V. BAG KZD - INFUSOR, PRESSURE, FOR I. V. BAGS PEDIATRIC POSITION HOLDER FRP - HOLDER, INFANT POSITION PATIENT EXAMINATION GLOVE LZB - FINGER COT FMC - GLOVE, PATIENT EXAMINATION LYY - GLOVE, PATIENT EXAMINATION, LATEX LZA - GLOVE, PATIENT EXAMINATION, POLY LZC - GLOVE, PATIENT EXAMINATION, SPECIALITY LYZ - GLOVE, PATIENT EXAMINATION, VINYL 880. 6375 PATIENT LUBRICANT KMJ - LUBRICANT, PATIENT 86 Q Q Initialled on 20 June 1997 US-EC MRA Medical Devices Annex 880. 6760 PROTECTIVE RESTRAINT BRT - RESTRAINT, PATIENT, CONDUCTIVE FMQ - RESTRAINT, PROTECTIVE NEUROLOGY PANEL (882) Section No. ************ * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * ** * * * * * * * * * * * * * ** Regulation Name Product Code - Device Name 882. 1030 882. 1420 882. 4060 882. 4545 882. 4650 - 882. 4750 ATAXIAGRAPH GWW - ATAXIAGRAPH ELECTROENCEPHALOGRAM (EEG) SIGNAL SPECTRUM ANALYZER GWS - ANALYZER, SPECTRUM, ELECTROENCEPHALOGRAM SIGNAL VENTRICULAR CANNULA HCD - CANNULA, VENTRICULAR SHUNT SYSTEM IMPLANTATION INSTRUMENT GYK - INSTRUMENT, SHUNT SYSTEM IMPLANTATION NEUROSURGICAL SUTURE NEEDLE HAS - NEEDLE, NEUROSURGICAL SUTURE SKULL PUNCH GXJ - PUNCH, SKULL OBSTETRICS AND GYNECOLOGY PANEL Section No. ************ * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * ** * * * * * * * * * * * * * ** Regulation Name Product Code - Device Name (NONE) 87 100 Initialled on 20 June 1997 US-EC MRA Medical Devices Annex OPHTHALMOLOGY PANEL (886) Section No. ************ * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * ** * * * * * * * * * * * * * ** Regulation Name Product Code - Device Name 886. 1780 886. 1940 886. 4070 886. 4300 886. 5850 RETINOSCOPE HKM - RETINOSCOPE, BATTERY-POWERED TONOMETER STERILIZER HKZ - STERILIZER, TONOMETER POWERED CORNEAL BURR HQS - BURR, CORNEAL, AC-POWERED HOG - BURR, CORNEAL, BATTERY-POWERED HRG - ENGINE, TREPHINE, ACCESSORIES, AC-POWERED HFR - ENGINE, TREPHINE, ACCESSORIES, BATTERY-POWERED HLD - ENGINE, TREPHINE, ACCESSORIES, GAS-POWERED KERATOME HNO - KERATONE, AC-POWERED HMY - KERATONE, BATTERY-POWERED SUNGLASSES (NON-PRESCRIPTION) HQY - SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) ORTHOPEDIC PANEL (888) Section No. ************ * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * ** * * * * * * * * * * * * * ** Regulation Name Product Code - Device Name 888. 1500 888. 4150 AC-POWERED GONIOMETER KQX - GONIOMETER, AC-POWERED CALIPERS FOR CLINICAL USE KTZ - CALIPER 88 j[ Q i Initialled on 20 June 1997 US-EC MRA Medical Devices Annex PHYSICAL MEDICINE PANEL (890) - Section No. ************ * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * ** * * * * * * * * * * * * * ** Regulation Name Product Code - Device Name 890. 3850 890. 5180 890. 5710 MECHANICAL WHEELCHAIR LBE - STROLLER, ADAPTIVE IOR - WHEELCHAIR, MECHANICAL MANUAL PATIENT ROTATION BED INY - BED, PATIENT ROTATION, MANUAL HOT OR COLD DISPOSABLE PACK IMD - PACK, HOT OR COLD, DISPOSABLE RADIOLOGY PANEL (892) Section No. ************ * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * ** * * * * * * * * * * * * * ** Regulation Name Product Code - Device Name 892. 1100 892. 1110 892. 1300 892. 1320 892. 1330 892. 1410 SCINTILLATION GAMMA CAMERA IYX - CAMERA, SCINTILLATION (GAMMA) POSITRON CAMERA IZC - CAMERA, POSITRON NUCLEAR RECTILINEAR SCANNER IYW - SCANNER, RECTILINEAR, NUCLEAR NUCLEAR UPTAKE PROBE IZD - PROBE, UPTAKE, NUCLEAR NUCLEAR WHOLE BODY SCANNER JAM - SCANNER, WHOLE BODY, NUCLEAR NUCLEAR ELECTROCARDIOGRAPH SYNCHRONIZER IVY - SYNCHRONIZER, ELECTROCARDIOGRAPH, NUCLEAR 89 1 09 ,lJ X. \J Initialled on 20 June 1997 US - EC MRA Medical Devices Annex 892. 1890 892. 1910 892. 1960 892. 1970 892. 5650 RADIOGRAPHIC-FILM ILLUMINATOR IXC - ILLUMINATOR, RADIOGRAPHIC-FILM JAG - ILLUMINATOR, RADIOGRAPHIC-FILM, EXPLOSION-PROOF RADIOGRAPHIC GRID IXJ -GRID, RADIOGRAPHIC RADIOGRAPHIC INTENSIFYING SCREEN WAM - SCREEN, INTENSIFYING, RADIOGRAPHIC RADIOGRAPHIC ECG/RESPIRATQR SYNCHRONIZER IXO - SYNCHRONIZER, ECG/RESPIRATOR, RADIOGRAPHIC MANUAL RADIONUCLIDE APPLICATOR SYSTEM IWG - SYSTEM, APPLICATOR, RADIONUCLIDE, MANUAL GENERAL AND PLASTIC SURGERY PANEL (878) Section No. ************ * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * ** * * * * * * * * * * * * * ** Regulation Name Product Code - Device Name 878. 4200 INTRODUCTION/DRAINAGE CATHETER AND ACCESSORIES KGZ - ACCESSORIES, CATHETER GCE - ADAPTOR, CATHETER FGY - CANNULA, INJECTION GBA - CATHETER, BALLOON TYPE GBZ - CATHETER, CHOLANGIOGRAPHY GBQ - CATHETER, CONTINUOUS IRRIGATION GBY - CATHETER, EUSTACHIAN, GENERAL & PLASTIC SURGERY JCY - CATHETER, INFUSION GBX - CATHETER, IRRIGATION GBP - CATHETER, MULTIPLE LUMEN GBO - CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY GBN - CATHETER, PEDIATRIC, GENERAL & PLASTIC SURGERY 90 J- V O Initialled on 20 June 1997 US - EC MRA Medical Devices Annex GBW - CATHETER, PERITONEAL GBS - CATHETER, VENTRICULAR, GENERAL & PLASTIC SURGERY GCD - CONNECTOR, CATHETER GCC - DILATOR, CATHETER GCB - NEEDLE, CATHETER REMOVABLE SKIN CLIP FZQ - CLIP, REMOVABLE (SKIN) SURGEON'S GLOVES KGO - SURGEON'S GLOVES NONPOWERED, SINGLE PATIENT, PORTABLE SUCTION APPARATUS GCY - APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED 878. 4320 878. 4460 878. 4680 878. 4760 REMOVABLE SKIN STAPLE GDT - STAPLE, REMOVABLE (SKIN) GENERAL AND PLASTIC SURGERY PANEL (878) (CONTINUED) Section No. ************ * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * ** * * * * * * * * * * * * * * ** Regulation Name Product Code - Device Name 878. 4820 AC-POWERED, BATTERY-POWERED, AND PNEUMATICALLY POWERED SURGICAL INSTRUMENT MOTOR GFG - BIT, SURGICAL GFA - BLADE, SAW, GENERAL & PLASTIC SURGERY DWH - BLADE, SAW, SURGICAL, CARDIOVASCULAR BRZ - BOARD, ARM (WITH COVER) GFE - BRUSH, DERMABRASION GFF - BUR, SURGICAL, GENERAL & PLASTIC SURGERY KDG - CHISEL (OSTEOTOME) GFD - DERMATOME GFC - DRIVER, SURGICAL, PIN GFB - HEAD, SURGICAL, HAMMER 91 104 Initialled on 20 June 1997 US - EC MRA Medical Devices Annex 878. 4960 GEY - MOTOR, SURGICAL INSTRUMENT, AC-POWERED GET - MOTOR, SURGICAL INSTRUMENT, PNEUMATIC POWERED DWI - SAW, ELECTRICALLY POWERED KFK - SAW, PNEUMATICALLY POWERED HAB - SAW, POWERED, AND ACCESSORIES AIR OR AC-POWERED OPERATING TABLE AND AIR OR AC-POWERED OPERATING CHAIR & ACCESSORIES GBB - CHAIR, SURGICAL, AC-POWERED FQO - TABLE, OPERATING-ROOM, AC-POWERED GDC - TABLE, OPERATING-ROOM, ELECTRICAL FWW - TABLE, OPERATING-ROOM, PNEUMATIC JEA - TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED 880. 5090 LIQUID BANDAGE KMF - BANDAGE, LIQUID 92 105 Initialled on 20 June 1997 US - EC MRA Medical Devices Annex TABLE 2 CLASS II MEDICAL DEVICES INCLUDED IN SCOPE OF PRODUCT COVERAGE AT BEGINNING OF TRANSITION PERIOD • U. S. to develop guidance documents identifying U. S. requirements and EC to identify standards needed to meet EC requirements RA 892. 1000 Diagnostic Ultrasound: RA 892. 1540 MAGNETIC RESONANCE DIAGNOSTIC DEVICE MOS - COIL, MAGNETIC RESONANCE. SPECIALTY LNH - SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING LNI - SYSTEM, NUCLEAR MAGNETIC RESONANCE SPECTROSCOPIC NONFETAL ULTRASONIC MONITOR JAF - MONITOR. ULTRASONIC, NONFETAL RA 892. 1550 ULTRASONIC PULSED DOPPLER IMAGING SYSTEM IYN - SYSTEM, IMAGING, PULSED DOPPLER. ULTRASONIC RA 892. 1560 ULTRASONIC PULSED ECHO IMAGING SYSTEM IYO - SYSTEM. IMAGING, PULSED ECHO, ULTRASONIC RA 892. 1570 DIAGNOSTIC ULTRASONIC TRANSDUCER ITX - TRANSDUCER, ULTRASONIC, DIAGNOSTIC Diagnostic X-Ray Imaging Devices (except mammographie x-ray systems): RA RA 892. 1600 892. 1650 ANGIOGRAPHIC X-RAY SYSTEM IZI - SYSTEM. X-RAY, ANGIOGRAPHIC IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM MQB - SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) JAA - SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED RA 892. 1680 STATIONARY X-RAY SYSTEM KPR - SYSTEM. X-RAY. STATIONARY RA 892. 1720 MOBILE X-RAY SYSTEM IZL - SYSTEM, X-RAY, MOBILE RA 892. 1740 TOMOGRAPHIC X-RAY SYSTEM IZF - SYSTEM, X-RAY, TOMOGRAPHIC RA 892. 1750 COMPUTED TOMOGRAPHY X-RAY SYSTEM JAK - SYSTEM. X-RAY, TOMOGRAPHY. COMPUTED ECG-Related Devices: CV 870. 2340 ELECTROCARDIOGRAPH DPS - ELECTROCARDIOGRAPH MLC - MONITOR. ST SEGMENT CV 870. 2350 ELECTROCARDIOGRAPH LEAD SWITCHING ADAPTOR DRW - ADAPTOR, LEAD SWITCHING. ELECTROCARDIOGRAPH CV 870. 2360 ELECTROCARDIOGRAPH ELECTRODE DRX - ELECTRODE, ELECTROCARDIOGRAPH CV 870. 2370 ELECTROCARDIOGRAPH SURFACE ELECTRODE TESTER KRC - TESTER. ELECTRODE. SURFACE, ELECTROCARDIOGRAPHIC NE 8821400 ELECTROENCEPHALOGRAPH 93 1 Q £> Initialled on 20 June 1997 US - EC MRA Medical Devices Annex HO 880. 5725 GWQ - ELECTROENCEPHALOGRAPH INFUSION PUMP (external only) MRZ - ACCESSORIES. PUMP, INFUSION FRN - PUMP, INFUSION LZF - PUMP. INFUSION. ANALYTICAL SAMPLING MEB - PUMP, INFUSION, ELASTOMERIC LZH - PUMP, INFUSION, ENTERAL MHD - PUMP. INFUSION, GALLSTONE DISSOLUTION LZG - PUMP, INFUSION, INSULIN MEA - PUMP, INFUSION, PCA Ophthalmic Instruments: OP 886. 1570 OPHTHALMOSCOPE HLI - OPHTHALMOSCOPE, AC-POWERED HLJ - OPHTHALMOSCOPE, BATTERY-POWERED OP 886. 1780 RETINOSCOPE HKL - RETINOSCOPE, AC-POWERED OP 886. 1850 AC-POWERED SLIT-LAMP BIOMICROSCOPE HJO - BIOMICROSCOPE. SLIT-LAMP, AC-POWERED OP 886. 4150 VITREOUS ASPIRATION AND CUTTING INSTRUMENT MMC - DILATOR. EXPANSIVE IRIS (ACCESSORY) HQE - INSTRUMENT, VITREOUS ASPIRATION AND CUTTING. AC-POWERED HKP - INSTRUMENT, VITREOUS ASPIRATION AND CUTTING, BATTERY-POWERED MLZ - VITRECTOMY, INSTRUMENT CUTTER OP 886. 4670 PHACOFRAGMENTATION SYSTEM HOC - UNIT, PHACOFRAGMENTATION SU 878. 4580 SURGICAL LAMP HBI - ILLUMINATOR, FIBEROPTIC, SURGICAL FIELD FTF - ILLUMINATOR. NON-REMOTE FTG - ILLUMINATOR, REMOTE HJE - LAMP, FLUORESCEIN. AC-POWERED FQP - LAMP, OPERATING-ROOM FTD - LAMP, SURGICAL GBC - LAMP, SURGICAL, INCANDESCENT FTA - LIGHT, SURGICAL, ACCESSORIES FSZ - LIGHT, SURGICAL, CARRIER FSY - LIGHT, SURGICAL, CEILING MOUNTED FSX - LIGHT. SURGICAL, CONNECTOR FSW - LIGHT, SURGICAL, ENDOSCOPIC FST - LIGHT. SURGICAL. FIBEROPTIC FSS - LIGHT. SURGICAL, FLOOR STANDING FSO - LIGHT. SURGICAL. INSTRUMENT NE 882. 5890 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR FOR PAIN RELIEF GZJ - STIMULATOR. NERVE. TRANSCUTANEOUS. FOR PAIN RELIEF Noninvasive Blood Pressure Measurement Devices: CV 870. 1120 BLOOD PRESSURE CUFF DXQ - CUFF. BLOOD-PRESSURE CV oscillometric) 870. 1130 NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM (except non- DXN - SYSTEM. MEASUREMENT. BLOOD-PRESSURE. NON-INVASIVE 94 107 Initialled on 20 June 1997 US - EC MRA Medical Devices Annex HO 880. 6880 STEAM STERILIZER (greater than 2 cubic feet) FLE - STERILIZER. STEAM Clinical Thermometers: 880. 2910 HO CLINICAL ELECTRONIC THERMOMETER (except tympanic or pacifier) FLL - THERMOMETER, ELECTRONIC, CLINICAL AN AN 868. 5630 NEBULIZER CAF - NEBULIZER (DIRECT PATIENT INTERFACE) 868. 5925 POWERED EMERGENCY VENTILATOR Hypodermic Needles and Syringes (except anti-stick and self-destruct): HO 880. 5570 HYPODERMIC SINGLE LUMEN NEEDLE MMK. - CONTAINER, SHARPES FMI - NEEDLE, HYPODERMIC. SINGLE LUMEN MHC - PORT, INTRAOSSEOUS. IMPLANTED HO 880. 5860 PISTON SYRINGE FMF - SYRINGE, PISTON OR 888. 3020 INTRAMEDULLARY FIXATION ROD HSB - ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES External Fixators (except devices with no external components): OR ACCESSORIES 888. 3030 COMPONENT OR 888. 3040 Selected Dental Materials: DE 872. 3060 SINGLE/MULTIPLE COMPONENT METALLIC BONE FIXATION APPLIANCES & KTT - APPLIANCE, FIXATION. NAIL/BLADE/PLATE COMBINATION, MULTIPLE SMOOTH OR THREADED METALLIC BONE FIXATION FASTENER HTY - PIN. FIXATION. SMOOTH JDW - PIN, FIXATION, THREADED GOLD BASED ALLOYS AND PRECIOUS METAL ALLOYS FOR CLINICAL USE EJT - ALLOY, GOLD BASED, FOR CLINICAL USE EJS - ALLOY, PRECIOUS METAL. FOR CLINICAL USE DE 872. 3200 RESIN TOOTH BONDING AGENT KLE - AGENT, TOOTH BONDING, RESIN DE 872. 3275 DENTAL CEMENT EMA - CEMENT. DENTAL EMB - ZINC OXIDE EUGENOL DE 872. 3660 IMPRESSION MATERIAL ELW - MATERIAL, IMPRESSION DE 872. 3690 TOOTH SHADE RESIN MATERIAL EBF - MATERIAL. TOOTH SHADE, RESIN DE 872. 3710 BASE METAL ALLOY EJH - METAL. BASE Latex Condoms: OB 884. 5300 CONDOM HIS - CONDOM 95 108 Initialled on 20 June 1997 US - EC MRA Medical Devices Annex TABLE 3 MEDICAL DEVICES FOR POSSIBLE INCLUSION IN SCOPE OF PRODUCT COVERAGE DURING OPERATIONAL PERIOD Anesthesiology Panel Section Product No Family Device Name Tier Anesthesia Devices 868. 5160 Gas machine for anesthesia or analgesia 2 868. 5270 Breathing system heater 868. 5440 Portable oxygen generator 868. 5450 Respiratory gas humidifier 868. 5630 Nebulizer - 868. 5710 Electrically powered oxygen tent 868. 5880 Anesthetic vaporizer Gas Analyser 868. 1040 Powered Algesimeter 868. 1075 Argon gas analyzer 868. 1400 Carbon dioxide gas analyzer 868. 1430 Carbon monoxide gas analyzer 868. 1500 Enflurane gas analyzer 868. 1620 Halothane gas analyzer 868. 1640 Helium gas analyzer 868. 1670 Neon gas analyzer 868. 1690 Nitrogen gas analyzer 868. 1700 Nitrous oxide gas analyzer 868. 1720 Oxygen gas analyzer, 868. 1730 Oxygen uptake computer 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 96 109 Initialled on 20 June 1997 US - EC MRA Medical Devices Annex Peripheral Nerve Stimulators Respiratory Monitoring 868. 2775 Electrical peripheral nerve stimulator 868. 1750 Pressure plethysmograph 868. 1760 Volume plethysmograph 868. 1780 Inspiratory airway pressure meter 868. 1800 Rhinoanemometer 868. 1840 Diagnostic spirometer 868. 1850 Monitoring spirometer 868. 1860 Peak-flow meter for spirometry 868. 1880 Pulmonary-function data calculator 868. 1890 868. 1900 868. 2025 868. 2375 868. 2480 868. 2500 868. 2550 Predictive pulmonary-function value calculator Diagnostic pulmonary-function interpretation calculator Ultrasonic air embolism monitor Breathing frequency monitor (except apnea detectors) Cutaneous carbon dioxide (PCCO2) monitor Cutaneous oxygen monitor (for an infant not under gas anesthesia) Pneumotachomometer 868. 2600 Airway pressure monitor 868. 5665 Powered percussor 868. 5690 Incentive spirometer Ventilator 868. 5905 Noncontinuous ventilator (IPPB) 868. 5925 Powered emergency ventilator 868. 5935 External negative pressure ventilator 868. 5895 Continuous ventilator 868. 5955 868. 6250 Intermittent mandatory ventilation attachment Portable air compressor 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 97 110 Initialled on 20 June 1997 US - EC MRA Medical Devices Annex Cardiovascular Panel Product Family Section No Device Name Tier Cardiovascular Diagnostic 870. 1425 Programmable diagnostic computer 870. 1450 Densitometer 870. 2310 Apex cardiograph (vibrocardiograph) 870. 2320 B allistocardiograph 870. 2340 Electrocardiograph 870. 2350 870. 2360 870. 2370 870. 2400 Electrocardiograph lead switching adaptor Electrocardiograph electrode Electrocardiograph surface electrode tester Vectorcardiograph 870. 2450 Medical cathode-ray tube display 870. 2675 Oscillometer 870. 2840 Apex cardiographic transducer 870. 2860 Heart sound transducer Cardiovascular Monitoring Valve, pressure relief, cardiopulmonary bypass Blood pressure alarm 870. 1100 870. 1110 Blood pressure computer 870. 1120 Blood pressure cuff 870. 1130 870. 1140 870. 1220 870. 1270 Noninvasive blood pressure measurement system Venous blood pressure manometer Electrode recording catheter or electrode recording probe Intracavitary phonocatheter system 870. 1875 Stethoscope (electronic) 2 2 2 2 2 1 2 2 1 1 2 2 2 2 2 2 2 2 2 2 2 98 111 Initialled on 20 June 1997 US - EC MRA Medical Devices Annex 870. 2050 870. 2060 870. 2100 Biopotential amplifier and signal conditioner Transducer signal amplifier and conditioner Cardiovascular blood flow-meter 870. 2120 Extravascular blood flow probe 870. 2300 870. 2700 Cardiac monitor (including cardiotachometer and rate alarm) Oximeter 870. 2710 Ear oximeter 870. 2750 Impedance phlebograph 870. 2770 Impedance plethysmograph - 870. 2780 870. 2850 Hydraulic, pneumatic, or photoelectric plethysmography Extravascular blood pressure transducer 870,2870 Catheter tip pressure transducer 870. 2880 Ultrasonic transducer 870. 2890 Vessel occlusion transducer 870. 2900 870. 2910 870. 2920 870. 4205 870. 4220 870. 4240 870. 4250 870. 4300 870. 4310 870. 4330 870. 4340 Patient transducer and electrode cable (including connector) Radiofrequency physiological signal transmitter and receiver Telephone electrocardiograph transmitter and receiver Cardiopulmonary bypass bubble detector Cardiopulmonary bypass heart-lung machine console Cardiovascular bypass heat exchanger Cardiopulmonary bypass temperature controller Cardiopulmonary bypass gas control unit Cardiopulmonary bypass coronary pressure gauge Cardiopulmonary bypass on-line blood gas monitor Cardiopulmonary bypass level sensing monitor and/or control 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 99 JL JL r-J Initialled on 20 June 1997 US - EC MRA Medical Devices Annex 870. 4370 870. 4380 870. 4410 870. 5050 Roller-type cardiopulmonary bypass blood pump Cardiopulmonary bypass pump speed control Cardiopulmonary bypass in-line blood 2as sensor Patient care suction apparatus 870. 5900 Thermal regulation system Cardiovascular Therapeutic Defibrillator 870. 5300 DC-defribrillator (including paddles) 870. 5325 Defibrillator tester Echocardiograph 870. 2330 Echocardiograph Pacemaker & Accessories 870. 1750 870. 3630 870. 3640 870. 3720 External programmable pacemaker pulse generator Pacemaker generator function analyzer Indirect pacemaker generator function analyzer Pacemaker electrode function tester Miscellaneous 870. 1800 Withdrawal-infusion pump 870. 2800 Medical magnetic tape recorder None Batteries, rechargeable, class II devices 2 2 2 2 2 2 2 2 2 2 2 2 2 2 100 113 Initialled on 20 June 1997 US - EC MRA Medical Devices Annex Dental Panel Product Family Section No Device Name Tier Dental Equipment 872. 1720 Pulp tester 872. 1740 Caries detection device 872. 4120 Bone cutting instrument and accessories 872. 4465 Gas-powered jet injector 872. 4475 Spring-powered jet injector 872. 4600 Intraoral ligature and wire lock 872. 4840 Rotary scaler 872. 4850 Ultrasonic scaler 872. 4920 872. 6070 Dental electrosurgical unit and accessories Ultraviolet activator for polymerization 872. 6350 Ultraviolet detector Dental Material 872. 3050 Amalgam alloy 872. 3060 872. 3200 Gold-based alloys and precious metal alloys for clinical use Resin tooth bonding agent 872. 3250 Calcium hydroxide cavity liner 872. 3260 Cavity varnish 872. 3275 872. 3300 Dental cement (other than zinc oxide- eugenol) Hydrophilic resin coating for dentures 872. 3310 Coating material for resin fillings 872. 3590 Preformed plastic denture tooth 872. 3660 Impression material 872,3690 Tooth shade resin material 872. 3710 Base metal alloy 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 101 114 Initialled on 20 June 1997 US - EC MRA Medical Devices Annex 872. 3750 872. 3760 872. 3765 Bracket adhesive resin and tooth conditioner Denture relining, repairing, or rebasing resin Pit and fissure sealant and conditioner 872. 3770 Temporary crown and bridge resin 872. 3820 872. 3920 Root canal filling resin (other than chloroform use) Porcelain tooth Dental X-ray 872. 1800 Extraoral source x-ray system 872. 1810 Intraoral source x-ray system Dental Implants 872. 4880 Intraosseous fixation screw or wires 872. 3890 Endodontic stabilizing splint Orthodontic 872. 5470 Orthodontic plastic bracket Ear/Nose/Throat Panel Product Family Section No Device Name Diagnostic Equipment 874. 1050 Audiometer 874. 1090 Auditory impedance tester 874. 1120 874. 1325 Electronic noise generator for audiometric testing Electroglottograph 874. 1820 Surgical nerve stimulator/locator 2 2 2 2 2 2 2 2 2 2 2 Tier 2 2 2 2 2 102 115 Initialled on 20 June 1997 US - EC MRA Medical Devices Annex Hearing Aids 874. 3300 Hearing aid (for bone-conduction) 874. 3310 874. 3320 874. 3330 Hearing aid calibrator and analysis system Group hearing aid or group auditory trainer Master hearing aid Surgical Equipment 874. 4250 874. 4490 874. 4500 Ear, nose, and throat electric or pneumatic surgical drill Argon laser for otology, rhinology, and laryngology ENT microsurgical carbon dioxide laser 2 2 2 2 1 2 2 Gastroenterologv/Urologv Panel Section No 876. 1500 Device Name Endoscope and accessories Tier 2 Product Family Endoscope (including angioscopes, laparscopes, ophthalmic endoscopes) 876. 4300 Endoscopic electrosurgical unit and accessories 2 Gastroenterology 876. 1725 Gastrointestinal motility monitoring 1 system Hemodialysis 876. 5600 876. 5630 876. 5665 876. 5820 876. 5830 Sorbent regenerated dialysate delivery system for hemodialysis Peritoneal dialysis system and accessories Water purification system for hemodialysis Hemodialysis system and accessories Hemodialyzer with disposable insert (kiil-type) 2 2 2 2 2 103 116 Initialled on 20 June 1997 US - EC MRA Medical Devices Annex Lithotriptor 876. 4500 Mechanical lithotriptor Urology Equipment 876. 1620 Urodynamics measurement system 876. 5320 876. 5880 Nonimplanted electrical continence device Isolated kidney perfusion and transport system and accessories General Hospital Panel 2 2 2 2 Product Family Section Device Name Tier No Infusion Pumps and Systems 880. 2420 880. 2460 880. 5430 Electronic monitor for gravity flow infusion systems Electrically powered spinal fluid pressure monitor Nonelectrically powered fluid injector 880. 5725 Infusion pump Neonatal Incubators 880. 5400 Neonatal incubator 880. 5410 Neonatal transport incubator 880. 5700 Neonatal phototherapy unit Piston Syringes 880. 5570 Hypodermic single lumen needle 880. 5860 Piston syringe (except anti-stick) 880. 6920 Syringe needle introducer Miscellaneous 880. 2910 Clinical electronic thermometer 880. 2920 Clinical mercury thermometer 880. 5100 AC-powered adjustable hospital bed 2 2 2 2 2 2 2 1 1 2 2 2 1 104 117 Initialled on 20 June 1997 US - EC MRA Medical Devices Annex 880. 5500 AC-powered patient lift 880. 6880 Steam Sterilizer (greater than 2 cubic feet) 2 2 Neurology Panel Product Family Section No Device Name Tier ? 7 882. 1020 Rigidity analyzer 882. 1610 Alpha monitor Neuro-Diagnostic 882. 1320 Cutaneous electrode 882. 1340 Nasopharyngeal electrode 882. 1350 Needle electrode 882. 1400 Electroencephalograph 882. 1460 Nystagmograph 882. 1480 Neurological endoscope 882. 1540 882. 1550 882. 1560 882. 1570 882. 1620 882. 1835 882. 1845 882. 1855 882. 5050 Galvanic skin response measurement device Nerve conduction velocity measurement device Skin potential measurement device Powered direct-contact temperature measurement device Intracranial pressure monitorins device Physiological signal amplifier Physiological signal conditioner Electroencephalogram (EEG) telemetry system Biofeedback device Echoencephalography 882. 1240 Echoencephalograph 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 105 118 Initialled on 20 June 1997 US - EC MRA Medical Devices Annex RPG 882. 4400 Radiofrequency lesion generator Neuro Surgery none Electrode, spinal epidural 882. 4305 882. 4310 882. 4360 Powered compound cranial drills, burrs, trephines, and their accessories Powered simple cranial drills burrs, trephines and accessories Electric cranial drill motor 882. 4370 Pneumatic cranial drill motor 882. 4560 Stereotaxic instrument 882. 4725 Radiofrequency lesion probe 882. 4845 Powered rongeur 882. 5500 Lesion temperature monitor Stimulators 882. 1870 Evoked response electrical stimulator 882. 1880 Evoked response mechanical stimulator 882. 1890 Evoked response photic stimulator 882. 1900 Evoked response auditory stimulator 882. 1950 Tremor transducer 882. 5890 Transcutaneous electrical nerve stimulator for pain relief 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 106 119 Initialled on 20 June 1997 US - EC MRA Medical Devices Annex Obstetrics/Gvnecologv Panel Product Family Fetal Monitoring Gynecological Surgery Equip. Section No 884. 1660 884. 1690 884. 2225 884. 2600 884. 2640 884. 2660 884. 2675 884. 2700 884. 2720 884. 2740 884. 2960 884. 1720 884. 4160 884. 4550 884. 4120 884. 5300 Device Name Tier Transcervical endoscope (amnioscope) and accessories Hysteroscope and accessories (for performance standards) Obstetric-gynecologic ultrasonic imager Fetal cardiac monitor Fetal phonocardiographic monitor and accessories Fetal ultrasonic monitor and accessories Fetal scalp circular (spiral) electrode and applicator Intrauterine pressure monitor and accessories External uterine contraction monitor and accessories Perinatal monitoring system and accessories Obstetric ultrasonic transducer and accessories Gynecologic laparoscope and accessories Unipolar endoscopic coagulator-cutter and accessories Gynecologic surgical laser Gynecologic electrocautery and accessories Condom 2 2 2 2 2 2 1 2 2 2 2 2 2 2 2 2 107 JL /*, \j Initialled on 20 June 1997 US - EC MRA Medical Devices Annex Product Family Section No Device Name Ophthalm. Implants Contact Lens 886. 3320 Eye sphere implant 886. 1385 886. 5916 Polymethylmethacrylate (PMMA) diagnostic contact lens Rigid gas permeable contact lens (daily wear only) Diagnostic Equipment 886. 1120 Opthalmic camera 886. 1220 Corneal electrode 886. 1250 Euthyscope (AC-powered) 886. 1360 Visual field laser instrument 886. 1510 Eye movement monitor 886. 1570 Ophthalmoscope 886. 1630 AC-powered photostimulator 886. 1640 Ophthalmic preamplifier 886. 1670 Ophthalmic isotope uptake probe 886. 1780 Retinoscope (AC-powered device) 886. 1850 ,AC-powered slitlamp biomicroscope 886. 1930 Tonometer and accessories 886. 1945 Transilluminator (AC-powered device) 886. 3130 Ophthalmic conformer 886. 4670 Phacofragmentation System 886. 3340 Extraocular orbital implant 886. 3800 Scleral shell (Diagnostic/ Surgery Equipment) Ophthalm. Implants Tier 2 2 2 2 2 1 2 2 2 2 108 121 Initialled on 20 June 1997 US - EC MRA Medical Devices Annex Surgical Equipment 880. 5725 Infusion pump (performance standards) 886. 3100 Ophthalmic tantalum clip 886. 3300 886. 4100 886. 4115 886. 4150 886. 4170 886. 4250 886. 4335 886. 4390 Absorbable implant (scleral buckling method) Radiofrequency electrosurgical cautery apparatus Thermal cautery unit Vitreous aspiration and cutting instrument Cryophthalmic unit Ophthalmic electrolysis unit (AC- powered device) Operating headlamp (AC-powered device) Ophthalmic laser 886. 4392 Nd:YAG laser for posterior capsulotomy 886. 4400 Electronic metal locator 886. 4440 AC-powered magnet 886. 4610 Ocular pressure applicator 886. 4690 Ophthalmic photocoagulator 886. 4790 Ophthalmic sponge 886. 5100 Ophthalmic beta radiation source none Ophthalmoscopes, replacement batteries, hand-held 2 2 2 2 2 2 2 1 1 2 2 1 1 2 2 2 2 1 Orthopedic Panel Product Family Section No Device Name Tier 109 1 oo JL fi*> ,'j Initialled on 20 June 1997 US - EC MRA Medical Devices Annex Implants 888. 3010 Bone fixation cerclage 888. 3020 Intramedullary fixation rod 888. 3030 888. 3040 888. 3050 888. 3060 Single/multiple component metallic bone fixation appliances and accessories Smooth or threaded metallic bone fixation fastener Spinal interlaminal fixation orthosis Spinal intervertebral body fixation orthosis Surgical Equipment 888. 1240 AC-powered dynamometer 888. 4580 none none none none, none none Sonic surgical instrument and accessories/attachments Accessories, fixation, spinal interlaminal Accessories, fixation, spinal intervertebral body Monitor, pressure, intracompartmental Orthosis, fixation, spinal intervertebral fusion Orthosis, spinal pedicle fixation System, cement removal extraction 1 2 2 2 2 2 2 2 2 2 2 1 2 Physical Medicine Panel Product Family Section No Device Name Diagnostic Equipment 890. 1225 Chronaximeter 890. 1375 Diagnostic electromyograph 890. 1385 890. 1450 Diagnostic electromyograph needle electrode Powered reflex hammer 890. 1850 Diagnostic muscle stimulator or (Therapy) 890. 5850 Powered muscle stimulator Tier 2 2 2 2 2 2 110 123 Initialled on 20 June 1997 US - EC MRA Medical Devices Annex Therapeutic Equipment 890. 5100 Immersion hydrobath 890. 5110 Paraffin bath 890. 5500 Infrared lamp 890. 5720 Water circulating hot or cold pack 890. 5740 Powered heating pad 2 2 2 2 2 Radiology Panel Product Family Section No Device Name Tier MRI 892. 1000 Magnetic resonance diagnostic device 2 Ultrasound Diagnostic 884. 2660 892. 1540 892. 1560 892. 1570 892. 1550 Fetal ultrasonic monitor and accessories Nonfetal ultrasonic monitor Ultrasonic pulsed echo imaging system Diagnostic ultrasonic transducer Ultrasonic pulsed doppler imaging system Angiographic 892. 1600 Angiographic x-ray system 2 2 2 2 111 124 Initialled on 20 June 1997 US - EC MRA Medical Devices Annex Diagnostic X-Ray 892. 1610 Diagnostic x-ray beam-limiting device 892. 1620 Cine or spot fluorographic x-ray Camera 892. 1630 Electrostatic x-ray imaging system 892. 1650 892. 1670 Image-intensified fluoroscopic x-ray system Spot film device 892. 1680 Stationary x-ray system 892. 1710 Mammographic x-ray system 892. 1720 Mobile x-ray system 892. 1740 Tomographic x-ray system 892. 1820 Pneumoencephalographic chair 892. 1850 Radiographic film cassette 892. 1860 Radiographic film/cassestte changer 892. 1870 892. 1900 Radiographic film/cassette changer programmer Automatic radiographic film processor 892. 1980 Radiologic table CT Scanner 892. 1750 Computed tomography x-ray system Radiation Therapy * 892. 5050 892. 5300 892. 5700 892. 5710 Medical charged-particle radiation therapy system Medical neutron radiation therapy system Remote controlled radionuclide- applicator system Radiation therapy beam-shaping block 892. 5730 Radionuclide brachytherapy source 892. 5750 Radionuclide radiation therapy system 892. 5770 892. 5840 Powered radiation therapy patient support assembly Radiation therapy simulation system 892. 5930 Therapeutic x-ray tube housing assembly 2 2 2 2 2 2 2 2 1 2 1 1 2 2 1 2 2 2 2 2 2 2 2 1 112 125 Initialled on 20 June 1997 US - EC MRA Medical Devices Annex Nuclear Medicine 892. 1170 Bone densitometer 892. 1200 892. 1310 Emission computed tomography system Nuclear tomography system 892. 1390 Radionuclide rebreathing system 2 2 1 2 General/Plastic Surgery Panel Product Family Section Device Name Tier No Surgical Lamps 878. 4630 890. 5500 Ultraviolet lamp for dermatologic disorders Infrared lamp 878. 4580 Surgical lamp Electrosurgical Cutting Equipment 878. 4810 878. 4400 Laser surgical instrument for use in general and plastic surgery and in dermatology Electrosurgical cutting and coagulation device and accessories Miscellaneous 878. 4780 Powered suction pump 2 2 2 2 2 2 113 126 Initialled on 20 June 1997 Financial Statement 1998-2002 External trade relations - Mutual Recognition Agreement 1. TITLE External Trade Relations- Mutual Recognition Agreements with United States, Canada. Australia, New Zealand and Israel. 2. BUDGETARY HEADINGS: B7-8500 A-7010 3. LEGAL BASIS • Article 113 of the Treaty of Rome • Proposal for Council decisions N°. on the implementation by the European Commission of mutual recognition agreements with United States, Canada, Australia, New Zealand and Israel. 4. DESCRIPTION OF OPERATION : 4. 1 General objective: The purpose of these agreements is to establish mutual recognition of certification of conformity of products with technical regulations or standards of partners to the agreement. The major actions which will be pursued by the Commission under this budget line will be the following: • Confidence-building activities to facilitate the proper implementation of the Agreement. • Management of the Agreements and maintenance of the necessary degree of confidence. The Commission will be assisted by experts, particularly in regard to sectoral activities. I activities. It will however remain the final arbiter in the management of these agreements. 4. 2 Duration of the action; means foreseen for its renewal: The general action undertaken will be of an indefinite duration. The initial period of confidence-building required by the Agreements will require a more intensive effort and expenditure, but this should be substantially less after 2 years. However, during the life of the Agreements a continued effort will be needed to ensure management and maintenance of confidence. 5. CLASSIFICATION OF EXPENDITURE/REVENUE 5. 7 Non-compulsory expenditure ("DNO") 5. 2 Differentiated appropriation ("CD") 5. 3 Type of revenue involved: None 127 6. TYPE OF EXPENDITURE/REVENUE - 100% subsidy: No - subsidy for co-financing with other sources in the public or private sector? Yes, this may be envisaged as a method of funding. Subsidies not normally exceeding 50% will be provided to professional associations and other responsible organisations for activities related to the implementation of the Agreement. - Interest subsidy: No - Others Financing of events, acquisition of studies, publications and conferences. - Should the action prove an economic success, is there provision for all, or part of the Community contribution to be reimbursed? Not relevant - Will the proposed operation cause any changes in the level of revenue? No 7. FINANCIAL IMPACT ON APPROPRIATIONS FOR OPERATIONS 7. 1 Method of calculating the total cost of the operation: The estimation of costs is based on the anticipated requirements in terms of expenses related to training, seminars, workshops, travel of experts, verification of conformity assessment bodies, information and studies. The total estimated cost is based on the sum of the individual actions. A range of different actions are foreseen to meet the objectives of the budget-line and costs will vary depending on the nature of action undertaken. Even for similar types of action (e. g. seminars) costs will vary depending on the scope of the action and the degree of specialisation needed. The costs of specific actions will be determined either: • by the Commission when it organises activities itself, e. g. seminars • • following invitations to tender issued by the Commission following requests for subsidies. In such cases, projects are selected according to how well they meet the criteria which have been established for selection. Subsidies are based on a percentage of total costs and usually the Community funding is limited to a maximum of 50%. A. Attendance at Joint Committee These will be attended by Commission officials and some national experts. Travel and per diem expenses should be foreseen within the normal range of such expenses. 128 B. Attendance at Joint Sectoral Groups These will also be attended by Commission officials and given the nature of these meetings a larger contingent of national experts. Travel and per diem expenses should be foreseen within the normal range of such expenses. C. Workshops and Seminars These will be held to familiarise economic and other operators with the requirements of the Agreement. The cost of these seminars will vary according to the subject matter and location, and will include organisational costs (when in Europe) and substantial travel costs when in the territory of the partner country. Organisational costs in Europe will cost c. 3000 ECUs each. The number of seminars will vary depending on the individual industrial sectors covered by the Agreement. D. Verification actions The competence of the conformity assessment bodies (CABs) will in many cases have to be checked, more so in the initial period of the Agreement, but as a matter of course throughout the life of the Agreement to maintain confidence in the system. This will involve on-site assessment by teams of experts of conformity assessment bodies in the partner country in the initial stages, and subsequently investigation of complaints. This expenditure will be essential in all sectors of the Agreement (. in number) and may involve numerous CABs in each sector including at subfederal or local level in certain cases. E. Production and dissemination of information Certain costs may need to be incurred for the dissemination of information. Guides to regulations and assessment procedures may be needed typically at a cost of 10 000 ECUs. 129 7. 2 Breakdown by elements of the operation "Trade Agreements with important Trading Partners" For 1998, this involves the following calculation: Budget Heading Amounts (Ecus) Joint Committee 12 940 B7-8500 Sectoral Groups B7-8500 Seminars B7-8500 57 680 103 540 Verifications ; 142 150 Method of calculation No. of missions Bxl Bxl Aus / NZ Israel 2 2 2 1 Standard Unit cost US: Travel: 2 000 Ecus; per diem: 185 Ecus Bxl US CAN US CAN Aus/NZ Bxl US CAN Aus/NZ Israel 16 8 8 10 10 14 28 18 18 12 1 CAN: Travel: 1 750 Ecus; per diem: 170 Ecus Aus / NZ: Travel: 3 200 Ecus; per diem: 190 Ecus Brussels: Travel: 800 Ecus; perdiem: 110 Ecus B7-8500 Information B7-8500 B7-8500 10 000 Total 326 310 150 In Ecus (current prices) Breakdown Year 1998 Year 1999 2000 2001 2002 Total 1998-2002 A. Joint Committee 12. 940 13 760 12 940 13 760 12 940 66 340 B. Joint Sectoral Groups 57 680 57 680 57 680 57 680 57 680 288 400 C. Seminars 103 540 96 310 199 850 D. Verifications 142 150 142 150 48 430 48 430 48 430 429 590 E. Information 10 000 10 000 10 000 30 000 Total 326 310 319 900 129 050 119 870 119 050 1014 180 From the year 2000 on the estimates are for information. 130 7. 3 Indication of the timetable for commitment and payment appropriations Year 1998 1999 2000 2001 2002 1000 Ecus 2003 and following years Total 326 319 129 119 119 119 1131 Schedule of Commitment Payment appropriations 1998 1999 2000 2001 2002 2003 326 319 129 119 119 326 319 129 119 119 119 1131 119 119 Total 326 319 129 119 119 8. WHAT ANTI-FRAUD MEASURES ARE PLANNED IN THE PROPOSAL FOR THE OPERATION ? Methods of control (submission of reports, etc. ) will be included in all contracts between the Commission and beneficiaries. A close cooperation with the delegations of the Commission and the participation of a representative of the Commission at events in third countries will check on the spot the work to ensure that it corresponds with the terms of reference, contract provisions and required professionalism. The checks take place before the final payment. The same rule applies to the financial incentives paid to participating companies. Where appropriate, agreements also require organisations to submit financial accounts certified by their auditors. In those eases involving cooperation with EU industrial federations the accounts are further checked at the Annual General Meeting of the federations concerned. 9. ELEMENTS OF COST-EFFECTIVENESS ANALYSIS 9. 1. Specific objectives of the proposed operation, population targeted - The specific objectives of mutual recognition agreements are: • • • to avoid duplication of certification by economic operators. to promote exports, employment, competitivity and investment. to reduce costs, in particular for small and medium-sized enterprises and ultimately for the consumer. - Target population The target population are the exporting companies, business associations, chambers of commerce and public institutions of the European Union and the general consumer which will benefit, or have an interest in, the mutual recognition of certification. 131 9. 2. Reasons for the operation - Need for intervention from the Community budget Under Article 113 of the Treaty of Rome the Community has exclusive competence for commercial policy and these agreements have been negotiated in accordance with a mandate of the Council of Ministers and in consultation with the 113 Committee. The Commission will be responsible for implementation and management of the agreements. - Choice of methods of intervention * advantages over alternative measures (comparative advantages) * analysis of similar operations at Community or national level * results and expected multipliers The choice of management method (Joint Committee and Joint Sectoral Groups) have been set out in the Agreements and constitute a minimum necessary for the proper functioning of the Agreement. The Agreements also contain provisions for the use of seminars in the initial phases to ensure familiarity with other systems. These seminars and verifications are also designed to build mutual confidence; verifications will also be required to ensure this confidence is maintained throughout the life of the agreements. Confidence and its maintenance are keys to the successful operation of the agreements. The importance of this budget is justified when put in perspective with the trade involved in these agreements and the yearly savings for EU exporters which are- expected (estimated on a yearly basis at 190 millions ECUs for EU exporters to the US, 20 mio in the case of exports to Canada and 40 mio in the case of exports to Australia and New Zealand). - Main factors of uncertainty which could affect the specific results of the operation. * None 9. 3 Monitoring and evaluation of the operation - Performance indicators selected * Output indicators * indicators of impact, following the objectives chosen In the case of these Agreements, success can be quantified by trade facilitation through avoidance of duplication of testing and certification and costs. Yearly estimated savings for the European Community are indicated above (9. 2). Success can also be measured by increased EU exports and this factor will be taken into consideration although export performance is subject to such a wide range of variables (e. g. changes in exchange rates) that this can never be the sole factor for evaluation. 132 - Evaluation of results Progress in the attainment of the Agreements objectives will be monitored by Commission officials, Committees established under the Agreements and by the economic operators concerned. Details and frequency of the planned evaluation The evaluation of the effectiveness and usefulness of the agreements wil be regularly monitored by the Commission and by the Committees established under the agreements at their annual meetings. The first major evaluation will be at the end of the confidence- building period. 10. ADMINISTRATIVE EXPENSES Actual mobilisation of the necessary administrative resources will depend on the Commission's annual decision on the allocation of resources, taking into account the number of staff and additional amounts authorised by the budgetary authority. There is no request for additional staff. 10. 1 Effect on the number of posts Type of post Staff to be assigned to managing the operation Permanent posts Temporary posts DGI + sectoral DGs. 3. 5 Officials A B C Source Duration Additional resources Existing resources in the DGs or departments concerned None 3. 5 None permanent Other resources Total None 1 4. 5 1 4. 5 10. 2 Overall financial impact of human resources: 4. 5 staff (107 500 Ecus per staff member per year = 483 750 Ecus). 10. 3 Increase in other administrative expenditure as a result of the operation (A-7010: travel expenses) The expenses set out below relate to travel expenses for officials of the Commission attending meetings of the Joint Committee, joint sectoral groups, seminars and verifications, when these are outside Brussels. These will be taken care of by the relevant budnet allocations of various Directorates Generals involved. 133 For 1998 this involves the following calculation: Budget heading Amounts (ECU) Method of calculation Joint Committee A-7010 Sectoral Groups A-7010 Seminars A-7010 Verifications 22 120 20 680 20 680 A-7010 142 150 A-7010 Total 205 630 No. of missions Aus / NZ Israel 4 4 Standard Unit cost US: Travel: 2 000 ECUs; per diem: 185 Ecus CAN: Travel: 1 750 Ecus; per diem: 170 Ecus Aus / NZ: Travel: 3 200 Ecus; per diem: 190 Ecus US CAN US CAN Aus / NZ US CAN Aus/NZ Israel 4 4 4 4 18 18 12 1 73 Year 1998 Year 1999 2000 2001 2002 Total 1998-2002 In ECU 22 120 20 680 22 120 20 680 22 120 107 720 20 680 20 680 20 680 20 680 20 680 103 400 A. Joint Committee B Joint Sectoral Groups C. Seminars 20 680 18 260 38 940 D. Verifications 142 150 142 150 48 430 48 430 48 430 429 590 TOTAL 205 630 201 770 91230 89 790 91230 679 650 1. o ^ IMPACT ASSESSMENT FORM THE IMPACT OF THE PROPOSAL ON BUSINESS with special reference to small and medium-sized enterprises Title of proposal Proposal for a Council Decision on the conclusion of an Agreement between the European Community and the United States on Mutual Recognition in relation to Conformity Assessment. Reference number The proposal The legislation is necessary to conclude an Agreement between the European Community and the United States on Mutual Recognition in relation to Conformity Assessment. Certificates and Markings. This is an agreement negotiated and initialled by the Commission in accordance with the mandate and negotiating directives provided by the Council on 21/9/92. The impact on business The business sectors affected are telecommunications terminal equipment, electrical equipment, recreational craft, medicinal products, and medical devices. The Agreement permits certification of conformity with technical regulations on product safety, etc, to be conducted in Europe for exports destined for the United States. This avoids the necessity for further certification by United States conformity assessment bodies before putting them oh the United States market. The Agreement therefore presents important advantages from the point of view of transparency, market access, avoidance of duplication especially of cost and general facilitation of trade. This is of particular importance for small and medium-sized enterprises. The Agreement covers a wide range of sectors spread throughout the Community and an extensive range of firms in these sectors both large and small, the advantages are not limited to specific geographical areas in the Community. Businesses will have to comply with United States regulations and procedures, but the certification, as stated above, will be conducted by conformity assessment bodies located in the Community and designated by the Member States, and not in the United States. The Agreement will substantially reduce certification costs and improve prospects for exports, employment, investment and competitiveness by European firms. The Agreement does not contain measures to take account of the specific situation of small and medium-sized firms, but by its nature and by reducing certification costs which are the same for all firms, the agreement will benefit small and medium sized enterprises to a greater extent proportionately than larger firms. _L \} o Consultation The main trade organisations in each sector eg Eurobit, Orgalime, EFPIA have been consulted and have universally declared their support for the Agreement. 136 EU TRADE WITH USA 1995 (MECU) IMPORT lllilHï m- H Products EXPORT nm • Pharmaceuticals Medical Devices Telephonic & Telegraphic Equipment 1867 2 966 2 000 1. 8 2. 9 1. 9 Pharmaceuticals Medical Devices Telephonic & Telegraphic Equipment Electrical Equipment 14 565 14. 1 Electrical Equipment Recreational Craft 212 0. 2 ' Recreational Craft 2216 1726 584 8 790 110 2. 1 1. 7 0. 6 8. 5 0. 1 Total 21610 20. 9 Total 13 426 13. 0 TOTAL 103 644 100. 0 TOTAL 103 284 100. 0 EU TRADE WITH USA 1996 (MECU) IMPORT EXPORT WrùÊMim Ifll Hi Products lisp m Pharmaceuticals Medical Devices Telephonic & Telegraphic Equipment 2518 3 509 2 869 2. 2 3. 1 2. 5 Pharmaceuticals Medical Devices Telephonic & Telegraphic Equipment Electrical Equipment 15 844 14. 1 Electrical Equipment Recreational Craft 216 0. 2 Recreational Craft 2 593 1770 729 9 793 138 2. 3 1. 5 0. 6 8. 6 0. 1 Total 24 956 22. 2 Total 15 024 13. 1 TOTAL 112 624 100. 0 TOTAL 114 309 100. 0 SOURCE: Pharmaceuticals: (ch 30) Medical Devices: (ch 9018, 9019, 9020, 9021, 9022) Telephonic & telegraphic Equipment: (ch 8517) Electrical Equipment: (ch 85) Recreational Craft: (ch 8903) Source: EUROSTAT (COMEXT) Brussels, 29 October 1997 137 ISSN 0254-1475 COM(98) 180 final DOCUMENTS EN 11 15 16 03 Catalogue number : CB-CO-98-194-EN-C ISBN 92-78-32511-2 Office for Official Publications of the European Communities L-2985 Luxembourg 138