7.12.98 Official Journal of the European Communities L 331/1 (Acts whose publication is obligatory) DIRECTIVE 98/79/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 October 1998 on in vitro diagnostic medical devices THE EUROPEAN PARLIAMENT AND THE COUNCIL OF trade, and whereas the need to establish THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 100a thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the Economic and Social Committee (2), Acting in accordance with the procedure laid down in Article 189b of the Treaty (3), (1) Whereas measures should be adopted for the smooth operation of the internal market; whereas the internal market is an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured; Whereas the content and scope of the laws, regulations and administrative provisions in force in the Member States with regard to the safety, health protection and performance, characteristics and authorisation procedures for in wvitro diagnostic medical devices are different; whereas the existence of such disparities creates barriers to (1) OJ C 172, 7.7.1995, p. 21 and OJ C 87, 18.3.1997, p. 9. () OJ C 18, 22.1.1996, p. 12. (%) Opinion of the European Parliament of 12 March 1996 (O] C 96, 1.4.1996, p. 31), Council common position of 23 March 1998 (O] C 178, 10.6.1998, p. 7) and Decision of the European Parliament of 18 June 1998 (O] C 210, 6.7.1998). Council Decision of 5 October 1998. harmonised rules has been confirmed by a comparative survey of national legislations carried out on behalf of the Commission; Whereas the harmonisation of national legislation is the only means of removing such barriers to free trade and of preventing new barriers from arising; whereas this objective cannot be achieved in a satisfactory manner by other means by the individual Member States; whereas this Directive lays down only such requirements as are necessary and sufficient to ensure, under the best safety conditions, free movement of the i vitro diagnostic medical devices to which it applies; Whereas the harmonised provisions must be distinguished from measures adopted by the Member States to manage the funding of public health and sickness insurance schemes relating directly or indirectly to such devices; whereas, therefore, the harmonised provisions do not affect the ability of the Member States to implement such measures provided that they comply with Community law; Whereas in vitro diagnostic medical devices should provide patients, users and third parties with a high level of health protection and attain the performance levels originally attributed to them by the manufacturer; whereas, therefore, maintenance or improvement of the level of health protection attained in the Member States is one of the main objectives of this Directive; Whereas, in accordance with the principles set out in the Council resolution of 7 May 1985 on a new approach to technical harmonisation and