29.1.2002 Official Journal of the European Communities L 25/47 COMMISSION DECISION of 25 January 2002 on the national provisions concerning HIV testing kits notified under Article 95(4) of the EC Treaty by the United Kingdom as regards Directive 98/79/EC on in vitro diagnostic medical devices (notified under document number C(2002) 297) (Text with EEA relevance) (2002/65EC) THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community and in particular Article 95(6) thereof, Whereas: I. FACTS 1. Community legislation: Directive 98/79/EC Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices () lays down harmonised rules concerning the safety, health protection an performance, characteristics and authorisation procedures for in vitro diagnostic medical devices, with a view to their placing on the market and putting into service. Directive 98/79/EC stipulates in Article 2 that the Member States shall take all necessary steps to ensure that devices may be placed on the market andfor put into service only if they comply with the requirements laid down by the Directive when duly supplied and properly installed, maintained and used in accordance with their intended purpose. Directive 98/79/EC stipulates in Article 4 that the Member States shall not create any obstacle to the placing on the market or the putting into service within their territory of devices bearing the EC marking indi- cating that they are considered to meet the requirements set out in the Directive. Directive 98/79/EC, in Annex I, contains specific label- ling requirements related to the product and its charac- teristics, including instructions for a proper and safe use. These requirements aim, among others, to inform users of the residual risks in relation with the product, as also to provide information on the identification of the device, on any special microbiological state, particular storage or handling conditions, particular operating instructions and appropriate precautions to take. () O] L 331, 7.12.1998, p. 1. 2. The notified national provisions The United Kingdom intends to maintain in force national provisions concerning HIV testing kits. These provisions are set out in the HIV testing kits and services regulations 1992 (SI 1992/460 — 1992 Regulations) and apply since 1 April 1992. The notification of the United Kingdom relates to ‘those provisions of the 1992 Regulations that potentially relate to the free movement of goods’. These are, according to the notification, the provisions, that make it an offence within the UK, to sell, supply or advertise, for sale or supply, a HIV testing kit or any component part of such a kit to a member of the public (Article 2 of the Regulations) and also these, that make it an offence to sell or supply a HIV testing kit that is not accompa- nied at the time of sale or supply in the United Kingdom by a notice indicating that it may not be supplied to a member of the public (Article 3(2)(a) of the Regulations), that a positive test should not be relied upon unless confirmed by at least one other test result, and that a negative test may not have detected recently acquired HIV (Article 3(2)(b) and (c) of the Regulations). The United Kingdom justifies its request by referring to the protection of life and public health. They consider it necessary to ensure the quality of HIV Testing Services and to underpin Government public health policy on HIV. In that context, individuals taking HIV tests should have the opportunity to receive pre-test discussion and post (positive) test counselling with a trained health care professional. Such discussions allow for the impact and consequences of a positive HIV test to be dealt with and for the communication of important advice on the prevention of transmission. II. PROCEDURE Directive 98/79/EC of the European Parliament and of the Council was adopted on 27 October 1998. Member States has to adopt and publish the national provisions necessary to comply with the Directive before 7 December 1999 and to apply them with effect from 7 June 2000.