Directiva 93-42-cee

1993L0042 — EN — 11.10.2007 — 005.001 — 1
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COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1)

Amended by: Official Journal No ►M1 ►M2 ►M3 ►M4 ►M5 Directive 98/79/EC of the European Parliament and of the Council of 27October 1998 Directive 2000/70/EC of the European Parliament and of the Council of 16 November 2000 Directive 2001/104/EC of the European Parliament and of the Council of 7 December 2001 Regulation (EC) No 1882/2003 of the European Parliament and of the Council of 29 September 2003 Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 L 331 L 313 L 6 L 284 L 247 page1 22 50 1 21 date 7.12.1998 13.12.2000 10.1.2002 31.10.2003 21.9.2007

1993L0042 — EN — 11.10.2007 — 005.001 — 2 ▼B COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices
THE COUNCIL OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof, Having regard to the proposal from the Commission(1), In cooperation with the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas measures should be adopted in the context 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, regulationsand administrative provisions in force in the Member States with regard to the safety, health protection and performance characteristics of medical devices are different; whereas the certification and inspection procedures for such devices differ from one Member State to another; whereas such disparities constitute barriers to trade within the Community; Whereas the national provisions for thesafety and health protection of patients, users and, where appropriate, other persons, with regard to the use of medical devices should be harmonized in order to guarantee the free movement of such devices within the internal market; Whereas the harmonized provisions must be distinguished from the measures adopted by the Member States to manage the funding of public health and sickness insuranceschemes relating directly or indirectly to such devices; whereas, therefore, the provisions do not affect the ability of the Member States to implement the abovementioned measures provided Community law is complied with; Whereas medical devices should provide patients, users and third parties with a high level of protection and attain the performance levels attributed to them by the manufacturer;whereas, therefore, the maintenance or improvement of the level of protection attained in the Member States is one of the essential objectives of this Directive; Whereas certain medical devices are intended to administer medicinal products within the meaning of Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative actionrelating to proprietary medicinal products (4); whereas, in such cases, the placing on the market of the medical device as a general rule is governed by the present Directive and the placing on the market of the medicinal product is governed by Directive 65/65/EEC; whereas if, however, such a device is placed on the market in such a way that the device and the medicinal product form a single integralunit which is intended exclusively for use in the given combination and which is not reusable, that single-unit product shall be governed by Directive 65/65/EEC; whereas a distinction must be drawn between the abovementioned devices and medical devices incorporating, inter alia, substances which, if used separately, may be considered to be a medicinal substance within the meaning of Directive...