EU IVDD 98-79-ec精品.pdfVIP

1998L0079 — EN — 20.11.2003 — 001.001 — 1 This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents ►B DIRECTIVE 98/79/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331, 7.12.1998, p. 1) Amended by: Official Journal No page date ►M1 Regulation (EC) No 1882/2003 of the European Parliament and of the L 284 1 31.10.2003 Council of 29 September 2003 Corrected by: ►C1 Corrigendum, OJ L 22, 29.1.1999, p. 75 (98/79/EC) ►C2 Corrigendum, OJ L 6, 10.1.2002, p. 70 (98/79/EC) 1998L0079 — EN — 20.11.2003 — 001.001 — 2 ▼B 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 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 wit hthe procedure laid down in Article 189b of