Agreement on mutual recognition between the European Community and the United States of America - Joint Declaration
4. 2. 1999 EN Official Journal of the European Communities L 31/3 on mutual recognition between the European Community and the United States of America AGREEMENT TABLE OF CONTENTS 1. Framework. 2. Telecommunication Equipment. 3. Electromagnetic Compatibility (EMC). 4. Electical Safety. 5. Recreational Craft. 6. Pharmaceutical Good Manufacturing Practices (GMPs). 7. Medical Devices. Page 4 13 21 27 32 36 49 L 31/4 EN Official Journal of the European Communities 4. 2. 1999 The EUROPEAN COMMUNITY, and THE UNITED STATES OF AMERICA, hereinafter referred to as ‘the Parties’, CONSIDERING the traditional links of friendship that exist between the United States of America (US) and the European Community (EC); DESIRING to facilitate bilateral trade between them; RECOGNISING that mutual recognition of conformity assessment activities is an important means of enhancing market access between the Parties; RECOGNISING that an agreement providing for mutual recognition of conformity assessment activities is of particular interest to small and medium-sized businesses in the US and the EC; RECOGNISING that any such mutual recognition also requires confidence in the continued reliability of the other Party’s conformity assessments; RECOGNISING the importance of maintaining each Party’s high levels of health, safety, environmental and consumer protection; RECOGNISING that mutual recognition agreements can positively contribute in encouraging greater international harmonisation 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; 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; RECOGNISING 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; RECOGNISING 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 — ‘Designation’ means a the Designating Authority of a conformity assessment body to perform conformity assessment procedures under this Agreement. identification by 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. — ‘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. 4. 2. 1999 EN Official Journal of the European Communities L 31/5 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 International for Standardisation 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. (ISO) and the Article 2 Purpose of the Agreement This Agreement specifies the conditions by which each Party will accept or recognise 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 in the Sectoral specified on a sector-specific basis 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 1. The United States shall, as specified in the Sectoral Annexes, accept or recognise 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. 2. The European Community and its Member States shall, as specified in the Sectoral Annexes, accept or recognise results of specified procedures, used in assessing conformity regulatory and administrative provisions of the European Community and its Member States, produced by the other Party’s conformity assessment bodies and/or authorities. legislative, specified to 3. 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 utilised assure conformity to 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. 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 this Agreement. in 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 regulation 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. Article 5 Transitional arrangements The Parties agree transitional commitments on confidence building as specified in the Sectoral Annexes. implement the to L 31/6 EN Official Journal of the European Communities 4. 2. 1999 1. The Parties agree that each sectoral transition arrangement shall specify a time period for completion. 2. The Parties may amend any transition arrangement by mutual agreement. 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. 3. Passage from the transitional phase to the operational phase shall proceed as specified in each Sectoral Annex, unless either Party documents the conditions provided in such Sectoral Annex for a successful transition are not met. that 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; (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 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 the contestation or to correct the deficiencies which form the basis of the contestation; information to refute in order (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 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; is required, (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 4. 2. 1999 EN Official Journal of the European Communities L 31/7 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; assessment (f) Upon the suspension of a conformity assessment body listed in a Sectoral Annex, a Party is no longer obligated to accept or recognise the results of conformity assessment procedures performed by that conformity to suspension. A Party shall continue to accept the results 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 subsequent conformity assessment body of instance, the Joint Sectoral Committee or the Joint joint Committee may decide verification of the completion of such verification, the proposal for withdrawal of the conformity assessment body may be resubmitted to the other Party; and the body concerned. After to carry out a (e) 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 environmental safety based on health, 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 10 Monitoring of conformity assessment bodies Article 9 The following shall apply with regard to the monitoring of conformity assessment bodies listed in a Sectoral Annex: 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; (d) 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 (a) Designating Authorities that shall assure 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 the Sectoral Annexes. Existing requirements of 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; (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. L 31/8 EN Official Journal of the European Communities 4. 2. 1999 Article 11 Article 14 Conformity assessment bodies Joint Committee of the Parties Each Party recognises that the conformity assessment bodies listed in the Sectoral Annexes fulfil the conditions of eligibility to assess conformity in relation to its requirements as specified in the Sectoral Annexes. The the conformity Parties shall specify assessment procedures for which such bodies are listed. the scope of Article 12 Exchange of information 1. The Parties shall exchange information concerning the regulatory, and implementation of the administrative provisions the Sectoral in Annexes. legislative, identified 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. identified consult as necessary with in the Sectoral 5. Regulatory Authorities Annexes their shall counterparts, to ensure the maintenance of confidence in conformity assessment procedures and to ensure that all technical requirements are identified and are satisfactorily addressed. Article 13 Sectoral contact points 1. The Parties hereby establish a Joint Committee consisting of representatives of each Party. The Joint Committee comprised 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 the Joint Committee. The Joint Committee shall make its decisions by unanimous consent. The Joint Committee shall determine its own rules and procedures. in 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 its Sectoral Annexes not this Agreement and otherwise resolved in the respective Joint Sectoral Committees; (d) providing a forum for discussion of issues that may this implementation of concerning the arise Agreement; (e) considering ways to enhance the operation of this Agreement; (f) coordinating the negotiation of additional Sectoral Annexes; and (g) considering whether to amend this Agreement or its Sectoral Annexes in accordance with Article 21. 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 Each Party shall appoint and confirm in writing contact points to be responsible for activities under each Sectoral Annex. 1. Nothing in this Agreement shall be construed to limit the authority of a Party to determine, through its 4. 2. 1999 EN Official Journal of the European Communities L 31/9 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. immediate measures whenever 2. Nothing in this Agreement shall be construed to limit the authority of a Regulatory Authority to take all appropriate and 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 its counterpart authority and the other Party within 15 days of taking such action, providing its reasons. takes such action, it shall inform Article 16 Suspension of recognition obligations Either Party may suspend its obligations under a 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 fulfil 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; Article 17 Confidentiality 1. Each Party agrees to maintain, to the extent required under information exchanged under this Agreement. the confidentiality of laws, its 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 unauthorised disclosure. Article 18 Fees Each Party shall endeavour 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. Article 20 Territorial application (c) the other Party fails to maintain legal and regulatory authorities capable of implementing the provisions of this Agreement. This Agreement shall apply, on the one hand, to the territories in which the Treaty establishing the European L 31/10 EN Official Journal of the European Communities 4. 2. 1999 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 Equipment, 1. This Agreement including its Sectoral Annexes on Telecommunication Electromagnetic Compatibility, Electrical Safety, Recreational Craft, Pharmaceutical Good Manufacturing Practices (GMPs), 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 from the date of notice. 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. 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 original 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. 4. 2. 1999 EN Official Journal of the European Communities L 31/11 Hecho en Londres, el dieciocho de mayo de mil novecientos noventa y ocho. Udfærdiget i London den attende maj nitten hundrede og otteoghalvfems. Geschehen zu London am achtzehnten Mai neunzehnhundertachtundneunzig. ˛γØνå óôï Λïνä νï, ó Øς äåï κÆ ïκôωï ΜÆØïυ łÝλØÆ åννØÆκÞ ØÆ åνåνηï νôÆ ïκôωï. Done at London on the eighteenth day of May in the year one thousand nine hundred and ninety-eight. Fait à Londres, le dix-huit mai mil neuf cent quatre-vingt-dix-huit. Fatto a Londra, addì diciotto maggio millenovecentonovantotto. Gedaan te Londen, de achttiende mei negentienhonderd achtennegentig. Feito em Londres, em dezoito de Maio de mil novecentos e noventa e oito. Tehty kahdeksantenatoista tuhatyhdeksänsataayhdeksänkymmentäkahdeksan. Lontoossa päivänä toukokuuta vuonna Som skedde i London den artonde maj nittonhundranittioåtta. Por la Comunidad Europea For Det Europæiske Fællesskab Für die Europäische Gemeinschaft ΓØÆ ôην ΕυρωðÆϊκηï ΚïØνÞôη Æ For the European Community Pour la Communaute´ europe´enne Per la Comunità europea Voor de Europese Gemeenschap Pela Comunidade Europeia Euroopan yhteisön puolesta På Europeiska gemenskapens vägnar L 31/12 EN Official Journal of the European Communities 4. 2. 1999 Por los Estados Unidos de Ame´rica For Amerikas Forenede Stater Für die Vereinigten Staaten von Amerika ΓØÆ Øς Ηνωµåï νåς ΠïλØôåÝåς ôης ΑµåρØκηï ς For the United States of America Pour les États-Unis d’Ame´rique Per gli Stati Uniti d’America Voor de Verenigde Staten van Amerika Pelos Estados Unidos da Ame´rica Amerikan yhdysvaltojen puolesta På Amerikas förenta staternas vägnar 4. 2. 1999 EN Official Journal of the European Communities L 31/13 SECTORAL ANNEX FOR TELECOMMUNICATION EQUIPMENT PREAMBLE This Annex constitutes a Sectoral Annex to the Agreement on Mutual Recognition of Conformity Assessment between the United States and the European Community. SECTION I LEGISLATIVE, REGULATORY AND ADMINISTRATIVE PROVISIONS EC USA Directive 98/13/EC of the European Parliament and of the Council of 12 February 1998 relating to telecommunications terminal equipment and satellite earth station equipment, including the mutual recognition of their conformity, and interpretation thereof; Communications Act of 1934, as amended by the Telecommunication Act of 1996, (Title 47 of the United States Code). The US regulatory and administrative provisions in respect of telecommunication equipment, including 47 CFR Part 68, and FCC interpretation thereof; (The Parties recognize that the Handbook on the implementation of Directive 98/13/EC (ADLNB and ACTE approved), provides useful guidelines for the implementation assessment of procedures falling under this Directive. ); conformity Commission Decisions (CTRs) established under Directive 98/13/EC; The EC Member States’ legislation and regulations in respect of: (a) non-harmonised analogue connection to the public telecommunications network (1); (b) non-harmonised radio transmitters for which is a civilian equipment authorisation there requirement; (The Parties recognize that the FCC Form 730 Application Guide provides useful guidelines for the assessment implementation procedures terminal equipment falling within these regulations. ); conformity telecommunication for of The US regulatory and administrative provisions in respect of all radio transmitters subject to an equipment A non-exclusive list of FCC regulations are contained in Section II; authorisation requirement. For electrical safety, see Electrical Safety Sectoral Annex to the Agreement; For electrical safety, see Electrical Safety Sectoral Annex to the Agreement; For electromagnetic compatibility aspects, Electromagnetic Compatibility Annex to the Agreement. see (EMC) Sectoral For electromagnetic compatibility aspects, Electromagnetic Compatibility Annex to the Agreement. see (EMC) Sectoral (1) The EC agrees to seek authority to include non-harmonised digital connections; L 31/14 EN Official Journal of the European Communities 4. 2. 1999 SECTION II SCOPE AND COVERAGE 1. 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 telecommunication terminal equipment, satellite terminal equipment, radio transmitters, and information technology equipment: (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 authorisation procedure by either Party. 2. The following is a non-exclusive list of the equipment, interfaces, and services included within the scope of this Sectoral Annex: EC USA 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 kbit/s unstructured — 2048 kbit/s structured — 34 Mbits/s access — 140 Mbits/s access — 2 wire analogue — 4 wire analogue 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-wire analog tie trunks/ops 4-wire analog tie trunks/ops PSTN Voice Band (Analog) Access Private Line (Analog) Access 4. 2. 1999 EN Official Journal of the European Communities L 31/15 EC USA Radio authorisation requirement, including: transmitters subject to an equipment Radio authorisation requirement, including: transmitters subject to an equipment — Short range devices, including low power devices Commercial Mobile Radio such as cordless telephones/microphones; — Land mobile, including: — Private Mobile Radio (PMR/PAMR) — Mobile telecom — Paging systems — Terrestrial fixed — Satellite mobile — Satellite fixed — Broadcast — Radio determination Domestic Public Fixed Domestic Mobile Personal Communication Service 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 (Part 20) (Part 21) (Part 22) (Part 24) (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) Note: A list of acronyms and a glossary is contained in Appendix I to this Sectoral Annex. Fixed Microwave Services (Part 101) CONFORMITY ASSESSMENT PROCEDURES FOR TELECOMMUNICATION EQUIPMENT SECTION III 1. Description of Mutual Recognition Obligations In accordance with the provisions of the Agreement, the result of the conformity assessment procedures produced by a Party’s conformity assessment bodies listed in Section V shall be recognised 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 recognises that the conformity assessment bodies of the other Party, listed in Section V, are authorised to perform the following procedures with regard to the importing Party’s technical requirements for telecommunication terminal, satellite terminal equipment, radio transmitters or information technology equipment: (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; and (c) performing quality assurance certification pursuant to Directive 98/13/EC. L 31/16 EN Official Journal of the European Communities 4. 2. 1999 AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES LISTED IN SECTION V SECTION IV EC USA National Institute of Standards and Technology (NIST) Federal Communications Commission (FCC) — Belgium Institut belge des services postaux et des te´le´communications Belgisch instituut telecommunicatie postdiensten voor en — Denmark Telestyrelsen — Germany Bundesministerium für Wirtschaft — Greece ΥðïυργåÝï Μå Ææïρωï ν κÆØ ΕðØκ ØνωνØωï ν Ministry of Transport and Communications — Spain Ministerio de Fomento — France Ministe`re de l’e´conomie, des finances et de l’industrie — Ireland Department of Transport, Energy and Communications — Italy Ministero delle Communicazioni — DGROS e ISETI (Radiotransmettitori) — Luxembourg Administration des Postes et Te´le´communi- cations — Netherlands De Minister van Verkeer en Waterstaat — Austria Bundesministerium für Wissenschaft und Verkehr — Portugal Instituto das Communicações de Portugal — Finland Liikenneministeriö/Trafikministeriet Telehallintokeskus/Teleförvaltningscentralen — Sweden Under the authority of the Government of Sweden: Styrelsen för ackreditering och teknisk kontroll (SWEDAC) — United Kingdom Department of Trade and Industry 4. 2. 1999 EN Official Journal of the European Communities L 31/17 SECTION V CONFORMITY ASSESSMENT BODIES EC access to the US market US access to the EC market 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 US 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) (to be provided by the US) DESIGNATING, LISTING, SUSPENDING, WITHDRAWING AND MONITORING CONFORMITY ASSESSMENT BODIES LISTED IN SECTION V SECTION VI EC access to the US market US access to the EC market identified in Section EC Authorities IV shall designate conformity assessment bodies located in the EC in accordance with the US 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, 65, etc. ) or the comparable EN-45000 Series Standards. identified in Section US Authorities IV shall designate conformity assessment bodies located in the US 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. 22, 25, 28, 58, 61, 62, 65, etc. ) for designating, listing, suspending, Procedures conformity withdrawing, assessment body in Section V shall be undertaken pursuant to Articles 7, 8, 9 and 10 of the Agreement. and monitoring listed a for designating, listing, suspending, Procedures conformity withdrawing, assessment body in Section V shall be undertaken pursuant to Articles 7, 8, 9 and 10 of the Agreement. and monitoring listed a 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 labelling and numbering requirements. The assignment of the numbers may take place in the territory of the L 31/18 EN Official Journal of the European Communities 4. 2. 1999 exporting Party. The numbers will be allocated by the importing Party. Numbering and labelling 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, labelled 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 favourable manner than for like domestic goods. 3. Joint Sectoral Committee 3. 1. A combined Joint Sectoral Committee for this Sectoral Annex and the Electromagnetic Compatibility (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. 3. 2. The JSC consists of representatives of the US and the EC for telecommunications and EMC. JSC representatives may each invite manufacturers and other entities as deemed necessary. The representatives for the US 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 US 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. 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 4. 2. 1999 EN Official Journal of the European Communities L 31/19 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; (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: (a) on receipt of tests reports, related documents and a first evaluation of conformity, the dossiers are promptly examined for completeness; (b) the applicant is informed in a precise and complete manner of any deficiency; (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. 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 US 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. L 31/20 EN Official Journal of the European Communities 4. 2. 1999 Appendix 1 Lists of acronyms and glossary ACTE ADLNB Approvals Committee for Terminal Equipment 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 Europe´enne (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 4. 2. 1999 EN Official Journal of the European Communities L 31/21 SECTORAL ANNEX FOR ELECTROMAGNETIC COMPATIBILITY (EMC) PREAMBLE This Annex constitutes a Sectoral Annex to the Agreement on Mutual Recognition of Conformity Assessment between the United States and the European Community. SECTION I LEGISLATIVE, REGULATORY AND ADMINISTRATIVE PROVISIONS EC USA Council Directive 89/336/EEC, as amended by Council Directive 92/31/EEC, and Directive 98/13/EC of the European Parliament and of the Council and interpretation thereof. Communications Act of 1934, as amended by the Telecommunication Act of 1996, (Title 47 of the United States Code), The US regulatory and administrative provisions in respect of equipment subject to electromagnetic requirements including: — 47 CFR Part 15 — 47 CFR Part 18, and FCC interpretation thereof. For electrical safety aspects see Electrical Safety Sectoral Annex to the Agreement. For electrical safety aspects see Electrical Safety Sectoral Annex to the Agreement. telecommunication For transmitters, Equipment Sectoral Annex to the Agreement. radio Telecommunication equipment and also see telecommunication For transmitters, Equipment Sectoral Annex to the Agreement. radio Telecommunication equipment and also see SECTION II SCOPE AND COVERAGE US access to the EC market EC access to the US market Any product falling under the scope of Council Directive 89/336/EEC. Any products falling under the scope of 47 CFR Part 15 and 18. L 31/22 EN Official Journal of the European Communities 4. 2. 1999 CONFORMITY ASSESSMENT PROCEDURES FOR EQUIPMENT IDENTIFIED IN SECTION II SECTION III 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 recognised 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 recognises that the conformity assessment bodies of the other Party, listed in Section V, are authorised 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 the 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. AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES LISTED IN SECTION V SECTION IV EC USA National Institute for Standards and Technology (NIST) Federal Communications Commission (FCC) Federal Aviation Administration (FAA) — Belgium Ministe`re des Affaires Economiques Ministerie van Economische Zaken — Denmark for telecommunication equipment: Telestyrelsen for other equipment: Danmarks Elektriske Materielkontrol (DEMKO) — Germany Bundesministerium für Wirtschaft — Greece ΥðïυργåÝï Μå Ææïρωï ν κÆØ ΕðØκ ØνωνØωï ν Ministry of Transport and Communications — Spain for telecommunication equipment: Ministerio de Fomento for other equipment: Ministerio de Industria y Energía — France Ministe`re de l’e´conomie, des finances et de l’industrie — Ireland Department of Transport, Energy and Communications 4. 2. 1999 EN Official Journal of the European Communities L 31/23 EC USA — Italy Ministero dell’Industria, del Commercio e dell’Artigianato — Luxembourg Ministe`re des Transports — Netherlands De Minister van Verkeer en Waterstaat — Austria for telecommunication equipment: Bundesministerium für Wissenschaft und Verkehr for other equipment: Bundesministerium für wirtschaftliche Angelegenheiten — Portugal Instituto das Comunicações de Portugal — Finland for telecommunication equipment: Liikenneministeriö/Trafikministeriet for other equipment: Kauppa- ja teollisuusministeriö/Handels- och industriministeriet — Sweden Under the authority of the Government of Sweden: Styrelsen för ackreditering och teknisk kontroll (SWEDAC) — United Kingdom Department of Trade and Industry SECTION V CONFORMITY ASSESSMENT BODIES EC access to the US market US access to the EC market 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 US 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) (to be provided by the US) L 31/24 EN Official Journal of the European Communities 4. 2. 1999 DESIGNATING, LISTING, SUSPENDING, WITHDRAWING AND MONITORING CONFORMITY ASSESSMENT BODIES LISTED IN SECTION V SECTION VI EC access to the US market US access to the EC market identified in Section EC Authorities IV shall designate conformity assessment bodies located in the EC in accordance with the US legislative, regulatory, and administrative provisions identified in 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. identified in Section US Authorities IV shall designate conformity assessment bodies located in the US 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. ). for designating, Procedures listing, suspending, withdrawing, conformity in Section V shall be assessment body undertaken pursuant to Articles 7, 8, 9, and 10 of the Agreement. and monitoring listed a for designating, Procedures listing, suspending, withdrawing, conformity in Section V shall be assessment body undertaken pursuant to Articles 7, 8, 9, and 10 of the Agreement. and monitoring listed a 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 Directive 93/465/EEC. 1. 2. The conformity assessment bodies shall record and retain details of its investigation of the competence and compliance of its sub-contractors 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 conformity 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 4. 2. 1999 EN Official Journal of the European Communities L 31/25 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. 3. 2. The JSC consists of representatives of the US and the EC for telecommunications and EMC. JSC representatives may each invite manufacturers and other entities as deemed necessary. The representatives for the US shall 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 US 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) 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; (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. SECTION VIII TRANSITIONAL ARRANGEMENT 1. There shall 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; L 31/26 EN Official Journal of the European Communities 4. 2. 1999 (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: (a) on receipt of test reports, related documents and a first evaluation of conformity, the dossiers are promptly examined for completeness; (b) the applicant is informed in a precise and complete manner of any deficiency; (c) any request for additional information is limited to omissions, inconsistencies or variances from the technical regulations or standards; (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. 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 US 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. 4. 2. 1999 EN Official Journal of the European Communities L 31/27 SECTORAL ANNEX FOR ELECTRICAL SAFETY PREAMBLE This Annex constitutes a Sectoral Annex to the Agreement on Mutual Recognition between the United States and the European Community. SECTION I LEGISLATIVE, REGULATORY AND ADMINISTRATIVE PROVISIONS US access to the EC market EC access to the US market Council Directive 73/23/EEC of 19 February 1973 as amended by Directive 98/13/EC of the European Parliament and of the Council. 29 USC 651 et seq. US 29 CFR 1910. 7 Products that are certified or approved under the Federal Mine Safety and Health Act (30 USC 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. Occupational Safety and Health Administration (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 Electromagnetic Compatibility (EMC) Sectoral Annex to this Agreement. For electromagnetic compatibility aspects, see the Electromagnetic Compatibility (EMC) Sectoral Annex to this Agreement. telecommunication For the Telecommunication Equipment Sectoral Annex to this Agreement. equipment, see telecommunication For the Telecommunication Equipment Sectoral Annex to this Agreement. equipment, see SECTION II SCOPE AND COVERAGE US access to the EC market EC access to the US market The electrical safety requirements of products falling under the scope of Council Directive 73/23/EEC on the harmonisation of the laws of the Member States relating to electrical equipment designed or use within certain voltage limits. The electrical safety requirements of products falling under the scope of 29 CFR 1910 subpart S. This includes the electrical safety aspects for workplace safety of medical equipment and telecommunication terminal equipment within the scope of those Sectoral Annexes. Products that are certified or approved under the Federal Mine Safety and Health Act (30 USC 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. L 31/28 EN Official Journal of the European Communities 4. 2. 1999 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 recognised to test, certify and mark products within the scope of their Nationally Recognised Testing Laboratory (NRTL) recognition for assessing conformity to US requirements. With regard to US 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 US shall be recognised under Article 11 of Council Directive 73/23/EEC as ‘bodies which may make a report in accordance with Article 8. ’ AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES LISTED IN SECTION V SECTION IV EC access to the US market US access to the EC market National Institute for Standards and Technology (NIST) — Belgium Ministe`re des Affaires Economiques Ministerie van Economische Zaken — Denmark Bygge- og Boligstyrelsen Danmarks Elektriske Materielkontrol (DEMKO) — Germany Bundesministerium für Arbeit und Sozialordnung — Greece ΥðïυργåÝï ΑνÀðôυŒης Ministry of Development — Spain Ministerio de Industria y Energía — France Ministe`re de l’e´conomie, des finances et de l’industrie — Ireland Department of Enterprise and Employment — Italy Ministero dell’Industria, del Commercio e dell’Artigianato — Luxembourg Ministe`re des Transports — Netherlands De Minister van Volksgezondheid, Welzijn en Sport 4. 2. 1999 EN Official Journal of the European Communities L 31/29 EC access to the US market US access to the EC market — Austria Bundesministerium für wirtschaftliche Angelegenheiten — Portugal Under the authority of the Government of Portugal: Instituto Portugueˆs da Qualidade — Finland Kauppa- industriministeriet ja teollisuusministeriö/Handels- och — Sweden Under the authority of the Government of Sweden: Styrelsen för ackreditering och teknisk kontroll (SWEDAC) — United Kingdom Department of Trade and Industry SECTION V CONFORMITY ASSESSMENT BODIES EC access to the US market US access to the EC market The names and responsibilities of scope of Conformity Assessment Bodies located in the EC and listed in accordance with this Sectoral Annex: The names and responsibilities of scope of Conformity Assessment Bodies located in the US and listed in accordance with this Sectoral Annex: (to the provided by the EC) (to be provided by the U. S. ) DESIGNATING, LISTING, SUSPENDING AND WITHDRAWING CONFORMITY ASSESSMENT BODIES SECTION VI EC access to the US market US access to the EC market Conformity assessment bodies from the EC shall be designated by the EC Authorities identified in Section IV and recognised by the Joint Committee, in accordance with the recognition procedures in the Agreement and this Annex. Conformity assessment bodies from the US shall be designated by the US Authority identified in Section IV and recognised by the Joint Committee, in accordance with the recognition procedures in the Agreement and Council Directive 73/23/EEC. Conformance with the appropriate ISO/IEC Guides or the corresponding EN-45000 series of standards shall be deemed consistent with US requirements identified in Section I. Conformance with the appropriate EN-45000 series of standards or the corresponding ISO/IEC Guides shall be deemed consistent with the requirements of Council Directive 73/23/EEC. L 31/30 EN Official Journal of the European Communities 4. 2. 1999 EC access to the US market US access to the EC market 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 US 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. For purposes of designating and listing, the US Designating Authority identified in Section IV shall designate conformity assessment bodies located in the US by filing a properly prepared proposal for listing with the EC, which includes a complete lab assessment under the following EC or Member State procedures, as appropriate. OSHA shall rely on the EC Designating Authorities identified in Section IV for conducting on-site reviews at the respective Member States’ conformity assessment bodies. The EC shall notify the US Designating Authority within 30 days as to whether the proposal is complete and shall indicate, where applicable, any additional information that is required. 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 recognition of conformity assessment bodies and confirm such a recognition by listing them in Section V of this Sectoral Annex. the Upon receipt of a complete proposal, the US exercising its authority under its law shall: in operational phase Equipment (a) prior to the passage from the transitional phase the into the Telecommunication and Electromagnetic Compatibility (EMC) Sectoral 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; in Equipment the operational phase (b) subsequent to passage from the transitional the phase into and Telecommunication 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 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. supersede shall EC conformity assessment bodies listed in Section V shall have NRTL status in the US. The US conformity assessment bodies listed in Section V shall have Notified Body status within the EC. 4. 2. 1999 EN Official Journal of the European Communities L 31/31 EC access to the US market US access to the EC market 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 procedures under its applicable domestic law. accordance with recognition in 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. SECTION VII JOINT SECTORAL COMMITTEE FOR ELECTRICAL SAFETY 1. The Joint Sectoral Committee for Electrical Safety (JSC/ES) consists of representatives of the US and the EC. OSHA shall represent the US 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. 2. The Joint 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. L 31/32 EN Official Journal of the European Communities 4. 2. 1999 SECTORAL ANNEX FOR RECREATIONAL CRAFT PREAMBLE This Annex constitutes a Sectoral Annex to the Agreement on Mutual Recognition between the United 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 18 months is arranged to build confidence as defined in this Sectoral Annex, Section VI. LEGISLATIVE, REGULATORY, AND ADMINISTRATIVE REQUIREMENTS SECTION I 1. For the European Community: Directive 94/25/EC of the European Parliament and of the Council of 16 June 1994 on the approximation of the laws, regulations, and administrative provisions of the Member States relating to recreational craft. 2. For the US: 46 USC Chapter 43, 33 CFR 81, 84, 159, 179, 181, 183 and 46 CFR 58. SECTION II SCOPE AND COVERAGE 1. 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. 2. 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/EC; (b) for the United States: Any product falling under the scope of 46 USC Chapter 43, 33 CFR 81, 84, 159, 179, 181, 183 and 46 CFR 58. 3. The Parties agree that for mutual recognition to operate under this Sectoral Annex, the following arrangements shall apply: (a) for approvals to European Community requirements, conformity assessment bodies designated by the US shall establish compliance as required to be demonstrated by Directive 94/25/EC. This demonstration of compliance shall be recognised in the European Community and products so certified shall have unrestricted access to the EC market for sale as recreational craft, pursuant to Section I; (b) 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 US market for sale as recreational craft, pursuant to Section I. 4. 2. 1999 EN Official Journal of the European Communities L 31/33 AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES SECTION III EC access to the US market US access to the EC market — Belgium des Communications Ministe`re l’infrastructure Ministerie van Verkeer en Infrastructuur et National Institute for Standards and Technology (NIST) de — Germany Bundesministerium für Wirtschaft — Spain Ministerio de Fomento — France Ministe`re de l’Equipment, des Transports et du Logement — Italy Ministero dell’Industria, del Commercio e dell’Artigianato — Netherlands De Minister van Verkeer en Waterstaat — Finland Merenkulkuhallitus/sjöfartsstyrelsen — Sweden Under the authority of the Government of Sweden: Styrelsen för ackreditering och teknisk kontroll (SWEDAC) — United Kingdom Department of Trade and Industry DESIGNATING, LISTING, SUSPENDING AND WITHDRAWING CONFORMITY ASSESSMENT BODIES SECTION IV 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 set out in Section V 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) for the European Community, bodies which are Notified Bodies in accordance with Directive 94/25/EC, are deemed to be in compliance with US requirements; (b) for the US, in accordance with the requirements set out in the regulations listed in Section I, the conformity assessment bodies listed in Section V are designated by NIST using the evaluation procedures contained in the appropriate EN-45000 series of standards or the corresponding ISO/IEC Guides. L 31/34 EN Official Journal of the European Communities 4. 2. 1999 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. SECTION V CONFORMITY ASSESSMENT BODIES EC access to the US market US access to the EC market The names and responsibilities of scope of Conformity Assessment Bodies located in the EC and listed in accordance with this Sectoral Annex: The names and responsibilities of scope of Conformity Assessment Bodies located in the US and listed in accordance with this Sectoral Annex: (to be provided by EC) (to be provided by the US) SECTION VI TRANSITIONAL ARRANGEMENT 1. There shall be a transitional period of 18 months prior to the operations of this Sectoral Annex. 2. The purpose of the transitional arrangement is to provide a mean whereby the Parties to this Agreement can cooperate to establish a system for designating conformity assessment bodies and can mutually build confidence in the abilities of these bodies. Successful completion of this transitional arrangement is intended to result in a determination 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. 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, legislative and regulatory changes necessary for the provisions of this Annex. 4. Product Scope All products covered by Section II of this Annex. 5. Cooperation During this transitional period, both Parties shall endeavour to sponsor jointly seminars for the purpose of improving the understanding of technical specifications applicable in each Party’s jurisdiction. 6. 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. 2. 1999 EN Official Journal of the European Communities L 31/35 SECTION VII ADDITIONAL PROVISIONS 1. 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. 2. 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 VIII DEFINITIONS ‘Notified Body’ means a third party authorised to perform the conformity assessment tasks specified in Directive 94/25/EC, 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/EC and has been notified to the Commission and to the other Member States. L 31/36 EN Official Journal of the European Communities 4. 2. 1999 SECTORAL ANNEX FOR PHARMACEUTICAL GOOD MANUFACTURING PRACTICES (GMPs) PREAMBLE This Annex constitutes a Sectoral Annex to the Agreement on Mutual Recognition between the United States and the European Community. 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 law, regulations, standards and commitments made as part of the approval to market a product. 3. ‘Good Manufacturing Practices’ (GMPs): (The US and EC have agreed to revisit these concepts) 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 possess. 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 Authorisation/Product Authorisation 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. ‘Inspection Report’ means the written observations and Good Manufacturing Practices compliance 5. assessment completed by an authority listed in Appendix 2. 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. 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 (GMPs) 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. 4. 2. 1999 EN Official Journal of the European Communities L 31/37 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 GMPs 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 EC) 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 Biologics Evaluation and Research as devices are not covered under this Annex. Appendix 3 contains an indicative list of products covered by this 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 Appendix 4. Information pertaining to the criteria under Community competence will be provided by the Community. 2. The authorities of the parties will establish and communicate to each other their draft programmes for assessing the equivalence of the respective regulatory systems in terms of quality assurance of the products and consumer protection. These programmes will be carried out, as deemed necessary by the authorities, for post- and pre-approval inspections and for various product classes or processes. L 31/38 EN Official Journal of the European Communities 4. 2. 1999 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 faith efforts to complete equivalence assessment as expeditiously as possible to the extent the resources of the authorities allow. 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). 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 currently listed as 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. 4. 2. 1999 EN Official Journal of the European Communities L 31/39 In addition, when an authority is not listed as equivalent based on adequate experience gained during the transition period, the Food and Drug Administration (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. In the EC, the qualified person will be relieved of responsibility for carrying out 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) issued by the manufacturer certifying that the product complies with requirements of the marketing authorisation and signed by the person responsible for releasing the batch/lot. 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 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 endeavour to respond to requests for clarification in a timely manner. indications of material include 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 within 90 calendar days of the request. Article 14 Transmission of pre-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 issued to be addressed during the inspection. A shorter time may be necessary in exceptional cases and these will be described in the request. L 31/40 EN Official Journal of the European Communities 4. 2. 1999 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 endorse normally the inspection reports of the suspended authority. A Party shall continue to endorse normally 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. CHAPTER 5 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 U. S. 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. 4. 2. 1999 EN Official Journal of the European Communities L 31/41 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. Article 19 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 recognises that the importing country has a right to fulfil 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. L 31/42 EN Official Journal of the European Communities 4. 2. 1999 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 28 September 1981 on the approximation of the laws of the Member States relating to veterinary medicinal products, as widened and amended. Council 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 (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products. Council Directive 92/25/EEC of 31 March 1992 on the wholesale distribution of medicinal products for human use. Guide to Good Distribution Practice (94/C 63/03). 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. 4. 2. 1999 EN Official Journal of the European Communities L 31/43 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: BELGIUM Inspection ge´ne´rale de la Pharmacie Algemene Farmaceutische Inspectie DENMARK Lægemiddelstyrelsen GERMANY Bundesministerium für Gesundheit GREECE ΕθνØκÞς ˆργÆνØóµ ς ΦÆρµÀκïυ Ministry of Health and Welfare National Drug Organization (E. O. F) SPAIN for medicinal products for human use: Ministerio de Sanidad y Consumo Subdirección General de Control Farmace´utico for medicinal products for veterinary use: Ministerio de Agricultura, Pesca y Alimentación (MAPA) Dirección General de la Producción Agraria FRANCE for medicinal products for human use: Agence du Me´dicament for veterinary medicinal products: Agence Nationale du Me´dicament Ve´te´rinaire IRELAND Irish Medicines Board ITALY for medicinal products for human use: Ministero della Sanità Dipartimento Farmaci e Farmacovigilanza for medicinal products for veterinary use: Ministero della Sanità Dipartimento alimenti e nutrizione e sanità pubblica veterinaria — Div. IX LUXEMBOURG Division de la Pharmacie et des Me´dicaments NETHERLANDS Staat der Nederlanden AUSTRIA Bundesministerium für Arbeit, Gesundheit und Soziales L 31/44 EN Official Journal of the European Communities 4. 2. 1999 PORTUGAL for human and veterinary (non-immunologicals): Instituto da Farmácia e do Medicamento — INFARMED for veterinary immunologicals: Direcção — Geral de Veterinaria FINLAND Lääkelaitos/Läkemedelsverket (National Agency for Medicines) SWEDEN Läkemedelsverket — Medical Products Agency UNITED KINGDOM for human and veterinary (non-immunologicals): Medicines Control Agency for veterinary immunologicals: Veterinary Medicines Directorate EUROPEAN COMMUNITY Commission of the European Communities European Agency for the Evaluation of Medicinal Products (EMEA) 4. 2. 1999 EN Official Journal of the European Communities L 31/45 Appendix 3 Indicative list of Products covered by the Sectoral Annex Recognising that precise definitions of medicinal products and drugs are to be found in the legislation 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 ingredients or bulk pharmaceuticals (US)/starting materials (EC). L 31/46 EN Official Journal of the European Communities 4. 2. 1999 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 and 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 pre-inspection preparation, including appropriate expertise of investigator/team, review of firm/product and databases, and availability of appropriate inspection equipment. 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 authorisations/approved applications. 4. 2. 1999 EN Official Journal of the European Communities L 31/47 VII. Additional specific criteria for pre-approval inspections A. Satisfactory demonstration through a jointly developed and administered training program and joint inspections to assess the authorities’ 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 access 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. L 31/48 EN Official Journal of the European Communities 4. 2. 1999 Appendix 5 Elements to be Considered in Developing a Two-way Alert System 1. Documentation — Defintion 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 E14 4HB, England. Telephone +44- 171- 418 8400, Fax 418 8416. for the United States: (to be provided by the U. S. ) 4. 2. 1999 EN Official Journal of the European Communities L 31/49 SECTORAL ANNEX ON MEDICAL DEVICES PREAMBLE This Annex constitutes a Sectoral Annex to the Agreement on Mutual Recognition in Regulation to Conformity Assessment between the United States and the European Community. 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. 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 programmes 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 Food and Drug Administration (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 US system, surveillance/post-market and initial/pre-approval inspection reports; (b) under the US 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 US regulatory requirements in a manner equivalent to those conducted by FDA; and CABs in the US are capable of conducting product and quality systems evaluations against EC regulatory requirements in a manner equivalent to those conducted by EC CABs. L 31/50 EN Official Journal of the European Communities 4. 2. 1999 Article 3 Product Coverage There are three components to this agreement each covering a discrete range of products: 1. Quality System Evaluations — US-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 US and EC law as medical devices. 2. Product Evaluation — US-type premarket (510(k)) product evaluation reports and EC-type-testing reports will be exchanged only with regard to those products classified under the US system as Class I/Class 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 US 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 Authorities 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. 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 programme 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. 4. 2. 1999 EN Official Journal of the European Communities L 31/51 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 US 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. 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 16. L 31/52 EN Official Journal of the European Communities 4. 2. 1999 3. Decisions concerning the equivalence of CABs must be agreed to by both Parties. 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. Article 11 Exchange and endorsement of quality system evaluation reports 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 reports; and (b) for surveillance quality system evaluations, EC CABs will provide abbreviated reports. 2. Listed US 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. If the abbreviated reports do not provide sufficient information, the importing Party may request 3. additional clarification from the CAB. 4. 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 endeavour 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 US medical device requirements. 2. US 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. 4. 2. 1999 EN Official Journal of the European Communities L 31/53 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 other specific evidence of serious concern in relation to product safety, performance, or quality. In such cases, the importing Party my request clarification from the exporting Party which may lead to a request for a re-evaluation. The parties will endeavour to respond to requests for clarification in timely manner. Endorsement remains the responsibility of the importing Party. 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 inspection, for cause, identified to the other Party. If the exporting Party cannot perform an inspection within a specified period time, the importing Party may perform an inspection on its own. 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 period, 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 Articles 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 SPECIAL 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. L 31/54 EN Official Journal of the European Communities 4. 2. 1999 2. The Committee will be co-chaired by a representative of the FDA for the US and a representative of the EC who will each have one vote. Decisions will be taken by unanimous consent. 3. The JSC’s functions will include: (a) making a joint assessment of the equivalent 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 of all authorities and 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 HARMONISATION AND INFORMATION EXCHANGE Article 18 Harmonisation During both the transitional and operational phases of this Agreement, both Parties intend to continue to participate in the activities of the Global Harmonisation Task Force and utilise the results of those activities to the extent possible. Such participation involves developing and reviewing documents developed by the Global Harmonisation 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 one another, as permitted by law, of, and consult one another 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 1. Article 20 Alert system and exchange of post-market vigilance reports 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. 4. 2. 1999 EN Official Journal of the European Communities L 31/55 Appendix 1 Relevant legislation, regulations and procedures 1. For the European Community the following legislation applies to Article 2(1): (a) Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices. Conformity assessment procedures. — Annex II (with the exception of section 4), — Annex IV, — Annex V; (b) Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. Conformity assessment procedures. — Annex II (with the exception of section 4), — Annex III, — Annex IV, — Annex V, — Annex VI. 2. For the United States, the following legislation applies to Article 2(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). L 31/56 EN Official Journal of the European Communities 4. 2. 1999 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) the 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 US. 4. Unless explicitly included by joint decision of the Parties, this agreement does not cover any US 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 1 June 1998, unless the Parties decide otherwise. 4. 2. 1999 EN Official Journal of the European Communities L 31/57 Class I products requiring premarket evaluations in the United States, included in scope of product coverage at beginning of transition period TABLE 1 Section No Regulation Name Product Code — Device Name 868. 1910 868. 5620 868. 5640 868. 5675 868. 5700 868. 6810 872. 3400 872. 3700 872. 4200 ANESTHESIOLOGY PANEL (868) 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 CARDIOVASCULAR PANEL (None) DENTAL PANEL (872) Karaya and sodium borate with or without acacia denture adhesive KOM — Adhesive, denture, acacia and karaya with sodium borate Dental mercury (USP) ELY — Mercury Dental handpieces and accessories EBW — Controller, foot, 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 874. 1070 874. 1500 EAR, NOSE, AND THROAT PANEL (874) Short increment sensitivity index (SISI) adapter ETR — Adapter, short increment sensitivity index (SISI) Gustometer ETM — Gustometer L 31/58 EN Official Journal of the European Communities 4. 2. 1999 Section No Regulation Name Product Code — Device Name 874. 1800 874. 1925 874. 3300 874. 4100 874. 5300 874. 5550 874. 5840 876. 5160 876. 5210 876. 5250 880. 5270 880. 5420 880. 5680 880. 6250 880. 6375 880. 6760 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 Anti-stammering device KTH — Device, anti-stammering GASTROENTEROLOGY — UROLOGY PANEL (876) Urological clamps for males FHA — Clamp, penile Enema kit FCE — Kit, enema, (for cleaning purpose) Urine collector and accessories FAQ — Bag, urine collection, leg, for external use GENERAL HOSPITAL PANEL (880) Neonatal eye pad FOK — Pad, neonatal eye Pressure infuser 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 Patient lubricant KMJ — Lubricant, patient Protective restraint BRT — Restraint, patient, conductive FMQ — Restraint, protective 4. 2. 1999 EN Official Journal of the European Communities L 31/59 Section No Regulation Name Product Code — Device Name 882. 1030 882. 1420 882. 4060 882. 4545 882. 4650 882. 4750 886. 1780 886. 1940 886. 4070 886. 4300 886. 5850 888. 1500 888. 4150 890. 3850 890. 5180 890. 5710 NEUROLOGY PANEL (882) Ataxiagraph GWW — Ataxiagraph Electroencephalogram (EEG) signal spectrum analyser GWS — Analyser, 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 (None) OPHTHALMOLOGY PANEL (886) 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 Keratone HNO — Keratone, ac-powered HMY — Keratone, battery-powered Sunglasses (non-prescription) HQY — Sunglasses (non-prescription including photosensitive) ORTHOPEDIC PANEL (888) Ac-powered goniometer KQX — Goniometer, ac-powered Callipers for clinical use KTZ — Calliper PHYSICAL MEDICINE PANEL (890) 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 L 31/60 EN Official Journal of the European Communities 4. 2. 1999 Section No Regulation Name Product Code — Device Name 892. 1100 892. 1110 892. 1300 892. 1320 892. 1330 892. 1410 892. 1890 892. 1910 892. 1960 892. 1970 892. 5650 RADIOLOGY PANEL (892) 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 synchroniser IVY — Synchroniser, electrocardiograph, nuclear Radiographic-film illuminator IXC — Illuminatore radiographic-film JAG — Illuminatore radiographic-film, explosion-proof Radiographic grid IXJ — Grid, radiographic Radiographic intensifying screen WAM — Screen, intensifying, radiographic Radiographic ECG/respirator synchroniser IXO — Synchroniser, ECG/respirator, radiographic Manual radionuclide applicator system IWG — System, applicator, radionuclide, manual 878. 4200 Introduction/drainage catheter and accessories GENERAL AND PLASTIC SURGERY PANEL (878) 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 GBW — Catheter, peritoneal GBS — Catheter, ventricular, general & plastic surgery GCD — Connector, catheter GCC — Dilator, catheter GCB — Needle, catheter 4. 2. 1999 EN Official Journal of the European Communities L 31/61 Section No Regulation Name Product Code — Device Name 878. 4320 878. 4460 878. 4680 878. 4760 878. 4820 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 Removable skin staple GDT — Staple, removable (skin) Ac-powered, battery-powered, and pneumatically powered surgical motor GFG — Bit, surgical GFA — Blade, saw, general and plastic surgery DWH — Blade, saw, surgical, cardiovascular BRZ — Board, arm (with cover) GFE — Brush, dermabrasion GFF — Bur, surgical, general and plastic surgery KDG — Chisel (osteotome) GFD — Dermatome GFC — Driver, surgical, pin GFB — Head, surgical, hammer 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 instrument 878. 4960 Air or ac-powered operating table and air or ac-powered operating chair and accessories GBB — Chair, surgical, ac-powered FQO — Tabel, operating-room, ac-powered GDC — Tabel, operating-room, electrical FWW — Tabel, operating-room, pneumatic JEA — Tabel, surgical with orthopedic accessories, ac-powered 880. 5090 Liquid bandage KMF — Bandage, liquid L 31/62 EN Official Journal of the European Communities 4. 2. 1999 Class II medical devices included in scope of product coverage at beginning of transition period (US to develop guidance documents identifying US requirements and EC to identify standards needed to meet EC requirements) TABLE 2 RA 892. 1000 Magnetic resonance diagnostic device MOS — Coil, magnetic resonance, specialty LNH — System, nuclear magnetic resonance imaging LNI — System, nuclear magnetic resonance spectroscopic DIAGNOSTIC ULTRASOUND RA 892. 1540 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 mammographic x-ray systems) RA 892. 1600 Angiographic x-ray system IZI — System, x-ray, angiographic RA 892. 1650 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 4. 2. 1999 EN Official Journal of the European Communities L 31/63 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 882. 1400 Electroencephalograph GWQ — Electroencephalograph HO 880. 5725 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 HQC — Unit, phacofragmentation L 31/64 EN Official Journal of the European Communities 4. 2. 1999 SU 878. 4580 Surgical lamp HBI — Illuminator, fiberoptic, surgical field FTF — Illuminator, non-remote FTG — Illuminator, remote HJE — Lamp, fluorescent, 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 FSQ — Light, surgical, instrument NE 882. 5890 Transcutaneous electrical nerve stimulator for pain relief GZJ — Stimulator, nerve, transcutaneous, for pain relief NON-INVASIVE BLOOD PRESSURE MEASUREMENT DEVICES CV 870. 1120 Blood pressure cuff DXQ — Cuff, blood-pressure CV 870. 1130 Non-invasive blood pressure measurement system (except non-oscillometric) DXN — System, measurement, blood-pressure, non-invasive HO 880. 6880 Steam steriliser (greater than 2 cubic feet) FLE — Steriliser, steam CLINICAL THERMOMETERS HO 880. 2910 Clinical electronic thermometer (except tympanic or pacifier) FLL — Thermometer, electronic, clinical AN 868. 5630 Nebuliser CAF — Nebuliser (direct patient interface) AN 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 4. 2. 1999 EN Official Journal of the European Communities L 31/65 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 888. 3030 Single/multiple component metallic bone fixation appliances and accessories KTT — Appliance, fixation, nail/blade/plate combination, multiple component OR 888. 3040 Smooth or threaded metallic bone fixation fastener HTY — Pin, fixation, smooth JDW — Pin, fixation, threaded SELECTED DENTAL MATERIALS DE 872. 3060 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 L 31/66 EN Official Journal of the European Communities 4. 2. 1999 Medical devices for possible inclusion in scope of product coverage during operational period TABLE 3 Product Family Section No Device Name Tier ANAESTHESIOLOGY PANEL Anesthesia Devices 868. 5160 Gas machine for anesthesia or analgesia 868. 5270 Breathing system heater 868. 5440 Portable oxygen generator 868. 5450 Respiratory gas humidifier 868. 5630 Nebuliser 868. 5710 Electrically powered oxygen tent 868. 5880 Anesthetic vaporiser Gas Analyzer 868. 1040 Powered Algesimeter 868. 1075 Argon gas analyser 868. 1400 Carbon dioxide gas analyser 868. 1430 Carbon monoxide gas analyser 868. 1500 Enflurane gas analyser 868. 1620 Halothane gas analyser 868. 1640 Helium gas analyser 868. 1670 Neon gas analyser 868. 1690 Nitrogen gas analyser 868. 1700 Nitrous oxide gas analyser 868. 1720 Oxygen gas analyser 868. 1730 Oxygen uptake computer 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 Predictive pulmonary-function value calculator 868. 1900 Diagnostic pulmonary-function interpretation calculator Peripheral Nerve Stimulators Respiratory Monitoring 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 2 2 2 2 2 4. 2. 1999 EN Official Journal of the European Communities L 31/67 Product Family Section No Device Name Tier 868. 2025 Ultrasonic air embolism monitor 868. 2375 Breathing frequency monitor (except apnea detectors) 868. 2480 Cutaneous carbon dioxide (PcCO2) monitor 868. 2500 Cutaneous oxygen monitor (for an infant not under gas anesthesia) 868. 2550 Pneumotachomometer 868. 2600 Airway pressure monitor 868. 5665 Powered percussor 868. 5690 Incentive spirometer Ventilator 868. 5905 Nonconinuous ventilator (IPPB) 868. 5925 Powered emergency ventilator 868. 5935 External negative pressure ventilator 868. 5895 Continuous ventilator 868. 5955 Intermittent mandatory ventilation attachment 868. 6250 Portable air compressor CARDIOVASCULAR PANEL Cardiovascular Diagnostic 870. 1425 Programmable diagnostic computer 870. 1450 Densitometer 870. 2310 Apex cardiograph (vibrocardiograph) 870. 2320 Ballistocardiograph 870. 2340 Electrocardiograph 870. 2350 Electrocardiograph lead switching adaptor 870. 2360 Electrocardiograph electrode 870. 2370 Electrocardiograph surface electrode tester 870. 2400 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 870. 1100 Blood pressure alarm 870. 1110 Blood pressure computer 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 1 2 2 1 1 2 2 2 2 2 L 31/68 EN Official Journal of the European Communities 4. 2. 1999 Product Family Section No Device Name Tier 870. 1120 Blood pressure cuff 870. 1130 Non-invasive blood pressure measurement system 870. 1140 Venous blood pressure manometer 870. 1220 Electrode recording catheter or electrode recording probe 870. 1270 Intracavitary phonocatheter system 870. 1875 Stethoscope (electronic) 870. 2050 Biopotential amplifier and signal conditioner 870. 2060 Transducer signal amplifier and conditioner 870. 2100 Cardiovascular blood flow-meter 870. 2120 Extravascular blood flow probe 870. 2300 Cardiac monitor (including) cardiotachometer and rate alarm) 870. 2700 Oximeter 870. 2710 Ear oximeter 870. 2750 Impedance phlebograph 870. 2770 Impedance plethysmograph 870. 2780 Hydraulic, pneumatic, or photoelectric plethysmographs 870. 2850 Extravascular blood pressure transducer 870. 2870 Catheter tip pressure transducer 870. 2880 Ultrasonic transducer 870. 2890 Vessel occlusion transducer 870. 2900 Patient transducer and electrode cable (including connector) 870. 2910 Radiofrequency physiological signal transmitter and receiver 870. 2920 Telephone electrocardiograph transmitter and receiver 870. 4205 Cardiopulmonary bypass bubble detector 870. 4220 Cardiopulmonary bypass heart-lung machine console 870. 4240 Cardiovascular bypass heat exchanger 870. 4250 Cardiopulmonary bypass temperature controller 870. 4300 Cardiopulmonary bypass gas control unit 870. 4310 Cardiopulmonary bypass coronary pressure gauge 870. 4330 Cardiopulmonary bypass on-line blood gas monitor 870. 4340 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 2 2 2 2 2 2 4. 2. 1999 EN Official Journal of the European Communities L 31/69 Product Family Section No Device Name Tier 870. 4370 Roller-type cardiopulmonary bypass blood pump 870. 4380 Cardiopulmonary bypass pump speed control 870. 4410 Cardiopulmonary bypass in-line blood gas sensor Cardiovascular Therapeutic 870. 5050 Patient care suction apparatus 870. 5900 Thermal regulation system Defibrillator 870. 5300 DC-defibrillator (including paddles) 870. 5325 Defibrillator tester Echocardiograph 870. 2330 Echocardiograph Pacemaker and Accessories 870. 1750 External programmable pacemaker pulse generator 870. 3630 Pacemaker generator function analyser 870. 3640 Indirect pacemaker generator function anlayser 870. 3720 Pacemaker electrode function tester Miscellaneous 870. 1800 Withdrawal-infusion pump 870. 2800 Medical magnetic tape recorder None Batteries, rechargeable, Class II devices DENTAL PANEL 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 Dental electrosurgical unit and accessories 872. 6070 Ultraviolet activator for polymerisation 872. 6350 Ultraviolet detector Dental Material 872. 3050 Amalgam alloy 872. 3060 Gold-based alloys and precious metal alloys for clinical use 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 2 2 2 L 31/70 EN Official Journal of the European Communities 4. 2. 1999 Product Family Section No Device Name Tier 872. 3200 Resin tooth bonding agent 872. 3250 Calcium hydroxide cavity liner 872. 3260 Cavity varnish 872. 3275 Dental cement (other than zinc oxide-eugenol) 872. 3300 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 872. 3750 Bracket adhesive resin and tooth conditioner 872. 3760 Denture relining, repairing, or rebasing resin 872. 3765 Pit and fissure sealant and conditioner 872. 3770 Temporary crown and bridge resin 872. 3820 Root canal filling resin (other than chloroform use) 872. 3920 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 stabilising splint Orthodontic 872. 5470 Orthodontic plastic bracket EAR/NOSE/THROAT PANEL Diagnostic Equipment 874. 1050 Audiometer 874. 1090 Auditory impedance tester 874. 1120 Electronic noise generator for audiometric testing 874. 1325 Electroglottograph 874. 1820 Surgical nerve stimulator/locator Hearing Aids 874. 3300 Hearing aid (for bone-conduction) 874. 3310 Hearing aid calibrator and analysis system 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 2 2 2 4. 2. 1999 EN Official Journal of the European Communities L 31/71 Product Family Section No Device Name Tier 874. 3320 Group hearing aid or group auditory trainer 874. 3330 Master hearing aid Surgical Equipment 874. 4250 Ear, nose, and throat electric or pneumatic surgical drill 874. 4490 Argon laser for otology, rhinology, and laryngology 874. 4500 ENT microsurgical carbon dioxide laser GASTROENTEROLOGY/UROLOGY PANEL 876. 1500 Endoscope and accessories 876. 4300 Endoscopic electrosurgical unit and accessories Endoscope (including angioscopes, laparscopes, ophtalmic endoscopes) Gastroenterology 876. 1725 Gastrointestinal motility monitoring system Hemodialysis 876. 5600 Sorbent regenerated dialysate delivery system for hemodialysis 876. 5630 Peritoneal dialysis system and accessories 876. 5665 Water purification system for hemodialysis 876. 5820 Hemodialysis system for accessories 876. 5830 Hemodialyser with disposable insert (kiil-type) Lithotriptor 876. 4500 Mechanical lithotriptor Urology Equipment 876. 1620 Urodynamics measurement system 876. 5320 Nonimplanted electrical continence device 876. 5880 Isolated kidney perfusion and transport system and accessories GENERAL HOSPITAL PANEL Infusion Pumps and Systems 880. 2420 Electronic monitor for gravity flow infusion systems 880. 2460 Electrically powered spinal fluid pressure monitor 880. 5430 Nonelectrically powered fluid injector 880. 5725 Infusion pump 2 2 1 2 2 2 2 1 2 2 2 2 2 2 2 2 2 2 2 2 2 L 31/72 EN Official Journal of the European Communities 4. 2. 1999 Product Family Section No Device Name Tier 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 880. 5500 AC-powered patient lift 880. 6880 Steam Steriliser (greater than 2 cubic feet) NEUROLOGY PANEL 882. 1020 Rigidity analyser 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 Galvanic skin response measurement device 882. 1550 Nerve conduction velocity measurement device 882. 1560 Skin potential measurement device 882. 1570 Powered direct-contact device temperature measurement 882. 1620 Intracranial pressure monitoring device 882. 1835 Physiological signal amplifier 882. 1845 Physiological signal conditioner 882. 1855 Electroencephalogram (EEG) telemetry system 882. 5050 Biofeedback device Echoencephalo- graphy 882. 1240 Echoencephalograph RPG 882. 4400 Radiofrequency lesion generator 2 2 2 1 1 2 2 2 1 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 4. 2. 1999 EN Official Journal of the European Communities L 31/73 Product Family Section No Device Name Tier Neuro Surgery none Electrode, spinal epidural 882. 4305 Powered compound cranial drills, burrs, trephines and their accessories 882. 4310 Powered simple cranial drills, burrs, trephines and accessories 882. 4360 Electric cranial drill motor 882. 4370 Pneumatic cranial drill motor 882. 4560 Sterotaxic 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 OBSTETRICS/GYNAECOLOGY PANEL Fetal Monitoring 884. 1660 Transcervical endoscope (amnioscope) and accessories 884. 1690 Hysteroscope and accessories standards) (for performance 884. 2225 Obstetric-gynecologic ultrasonic imager 884. 2600 Fetal cardiac monitor 884. 2640 Fetal phonocardiographic monitor and accessories 884. 2660 Fetal ultrasonic monitor and accessories 884. 2675 Fetal scalp circular (spiral) electrode and applicator 884. 2700 Intrauterine pressure monitor and accessories 884. 2720 External uterine contraction monitor and accessories 884. 2740 Perinatal monitoring system and accessories 884. 2960 Obstetric ultrasonic transducer and accessories 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 1 2 2 2 2 L 31/74 EN Official Journal of the European Communities 4. 2. 1999 Product Family Section No Device Name Tier Gynecological Surgery Equipment 884. 1720 Gynecologic laparoscope and accessories 884. 4160 Unipolar endoscopic coagulator-cutter and accessories 884. 4550 Gynecologic surgical laser 884. 4120 Gynecologic electrocautery and accessories 884. 5300 Condom Ophthalm. Implants 886. 3320 Eye sphere implant Contact Lens 886. 1385 Polymethylmethacrylate (PMMA) diagnostic contact lens 886. 5916 Rigid gas permeable contact lens (daily wear only) Diagnostic Equipment 886. 1120 Ophthalmic 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 886. 5725 Infusion pump (performance standards) 886. 3100 Ophthalmic tantalum clip 886. 3300 Absorbable implant (scleral buckling method) 886. 4100 Radiofrequency electrosurgical cautery apparatus (Diagnostic/ Surgery Equipment) Ophthalm. Implants Surgical Equipment 2 2 2 2 2 2 2 2 1 1 1 1 1 1 1 1 2 1 1 2 1 2 2 2 2 2 2 2 2 4. 2. 1999 EN Official Journal of the European Communities L 31/75 Product Family Section No Device Name Tier 886. 4115 Thermal cautery unit 886. 4150 Vitreous aspiration and cutting instrument 886. 4170 Cryophthalmic unit 886. 4250 Ophthalmic electrolysis unit (AC-powered device) 886. 4335 Operating headlamp (AC-powered device) 886. 4390 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 ORTHOPEDIC PANEL Implants 888. 3010 Bone fixation cerclage 888. 3020 Intramedullary fixation rod 888. 3030 Single/multiple component metallic bone appliance and accessories fixation 888. 3040 Smooth or threaded metallic bone fixation 888. 3050 Spinal interlaminal fixation orthosis 888. 3060 Spinal intervertebral body fixation orthosis Surgical Equipment 888. 1240 AC-powered dynamometer 888. 4580 Sonic surgical instrument and accessories/attachments none none none none none none 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 2 2 2 1 1 2 2 1 1 2 2 2 2 1 2 2 2 2 2 2 2 2 2 2 1 2 1 L 31/76 EN Official Journal of the European Communities 4. 2. 1999 Product Family Section No Device Name Tier PHYSICAL MEDICINE PANEL Diagnostic Equipement 890. 1225 Chronaximeter 890. 1375 Diagnostic electromyograph 890. 1385 Diagnostic electromyograph needle electrode 890. 1450 Powered reflex hammer 890. 1850 Diagnostic muscle stimulator or (Therapy) 890. 5850 Powered muscle stimulator 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 RADIOLOGY PANEL MRI 892. 1000 Magnetic resonance diagnostic device Ultrasound Diagnostic 884. 2660 Fetal ultrasonic monitor and accessories 892. 1540 Nonfetal ultrasonic monitor 892. 1560 Ultrasonic pulsed echo imaging system 892. 1570 Diagnostic ultrasonic transducer 892. 1550 Ultrasonic pulsed doppler imaging system Angiographic 892. 1600 Angiographic x-ray system 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 Image-intensified fluoroscopic x-ray system 892. 1670 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 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 1 2 1 4. 2. 1999 EN Official Journal of the European Communities L 31/77 Product Family Section No Device Name Tier 892. 1860 Radiographic film/cassette changer 892. 1870 Radiographic film/cassette changer programmer 892. 1900 Automatic radiographic film processor 892. 1980 Radiologic table CT Scanner 892. 1750 Computed tomography x-ray system Radiation Therapy 892. 5050 Medical charged-particle radiation therapy system 892. 5300 Medical neutron radiation therapy system 892. 5700 Remote controlled radionuclide-applicator system 892. 5710 Radiation therapy beam-shaping block 892. 5730 Radionuclide brachytherapy source 892. 5750 Radionuclide radiation therapy system 892. 5770 Powered radiation therapy patient support assembly 892. 5840 Radiation therapy stimulation system 892. 5930 Therapeutic x-ray tube housing assembly Nuclear Medicine 892. 1170 Bone densitometer 892. 1200 Emission computed tomography system 892. 1310 Nuclear tomography system 892. 1390 Radionuclide rebreathing system GENERAL/PLASTIC SURGERY PANEL Surgical Lamps 878. 4630 Ultraviolet lamp for dermatologic disorders 890. 5500 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 1 2 2 1 2 2 2 2 2 2 2 2 2 1 2 2 1 2 2 2 2 2 2 2 L 31/78 EN Official Journal of the European Communities 4. 2. 1999 Appendix 3 Authorities responsible for designating conformity assessment bodies EC access to the US market US access to the EC market — Belgium Food and Drug Administration (FDA) la de publique, Ministe`re l’Environnement et de l’Inte´gration sociale Ministerie van Volksgezondheid, Leefmilieu en Sociale Inetgratie Sante´ de — Denmark Sundhedsministeriet — Germany Bundesministerium für Gesundheit — Greece ΥðïυργåÝï ΥγåÝÆς Ministry of Health — Spain Ministerio de Sanidad y Consumo — France Ministe`re de l’emploi et de la solidarite´ Ministe`re de l’e´conomie, des finances et de l’industrie — Ireland Department of Health — Italy Ministero della Sanitá — Luxembourg Ministe`re de la Sante´ — Netherlands Staat der Nederlanden — Austria Bundesministerium für Arbeit, Gesundheit und Soziales — Portugal Ministerio da Saude — Finland Sosiaali-ja terveysministeriö/Social-och hälsovårdsministeriet — Sweden Under the authority of the Government of Sweden: Styrelsen för ackreditering och teknisk kontroll (SWEDAC) — United Kingdom Department of Health 4. 2. 1999 EN Official Journal of the European Communities L 31/79 Appendix 4 Conformity assessment bodies EC access to the US market US access to the EC market Conformity assessment bodies located in the EC shall be designated by the Authorities identified in Appendix 3. Conformity assessment bodies located in the US shall be designated by the Authorities identified in Appendix 3. (to be provided by the EC) (to be provided by the US) L 31/80 EN Official Journal of the European Communities 4. 2. 1999 to the Agreement on Mutual Recognition between the European Community and the United States of America JOINT DECLARATION The Parties agree that, although in this exceptional case the Agreement on Mutual Recognition between the United States of America and the European Community is being signed while the consistency of the various linguistic versions of the Agreement is being verified, notification of the completion of their respective procedures for the entry into force of the Agreement, as referred to in Article 21(1) of the Agreement, will be made only after the Parties have completed the verification of the texts signed today and, through agreement between the Parties, any discrepancies have been brought into conformity with the English text. Done at London on the eighteenth day of May in the year one thousand nine hundred and ninety-eight. For the European Community For the United States of America