1995/0013(COD)COM(1996)643

In Vitro Diagnostic Medical Devices Directive

Proposal for a EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE on in vitro diagnosis medical devices

Stage: No longer in force
Transposition deadline: 7 Dec 1999
Procedure: Directive · Ordinary legislative procedure
Last activity: 7 Dec 1998

3 acts

Delegated and implementing acts beneath it

By status: 3 published.

Act	Kind	Status	Adoption
Commission Implementing Decision (EU) 2020/439	Implementing · Decision	Published	Q1 2020
Commission Implementing Decision (EU) 2020/350	Implementing · Decision	Published
Commission Implementing Decision (EU) 2019/1244	Implementing · Decision	Published

Titles link to EUR-Lex where the act has been published.

13 documents

Documents

Newest first. Each opens at its source.

Text adopted · 32002D0364Commission
Report · A4-0031/1996Parliament
Report · A4-0225/1998Parliament
Text adopted · Directive 1998/0079Commission
OJ C 018 22.01.1996, p. 0012Commission
OJ C 078 18.03.1996, p. 0002Commission
OJ C 087 18.03.1997, p. 0009Commission
OJ C 096 01.04.1996, p. 0017-0031Commission
OJ C 172 07.07.1995, p. 0021Commission
OJ C 178 10.06.1998, p. 0007Commission
OJ C 210 06.07.1998, p. 0009Commission
Text adopted · OJ L 131 16.05.2002, p. 0017-0030Commission
Text adopted · OJ L 331 07.12.1998, p. 0001Commission

Summary

Generated

Directive 98/79/EC harmonizes EU rules for in vitro diagnostic medical devices, setting essential requirements, conformity assessment procedures, CE marking, and a vigilance system. It applies to reagents, calibrators, instruments, and specimen receptacles, with notified-body involvement for higher-risk devices. Member States had to apply it from 7 June 2000.

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Sources: EP Legislative Observatory · EU Law Tracker · EUR-Lex. Record as of 30 Sept 2026. Something wrong on this page? Report an error.

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