In Vitro Diagnostic Medical Devices Directive

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

Stage: In force
Transposition deadline: 7 Dec 1999
Procedure: Directive
Last activity: 27 Oct 1998

1 act

Delegated and implementing acts beneath it

By status: 1 published.

Act	Kind	Status	Adoption
Commission Delegated Regulation (EU) 2016/1851	Implementing · Decision	Published	Q1 2020

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

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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