1991/0353(SYN)

Medical Devices Directive

PROPOSAL FOR A COUNCIL DIRECTIVE CONCERNING MEDICAL DEVICES

Stage: No longer in force
Transposition deadline: 1 Jul 1994
Procedure: Directive · Cooperation procedure
Last activity: 12 Jul 1993

3 acts

Delegated and implementing acts beneath it

By status: 3 published.

Act	Kind	Status	Adoption
Commission Implementing Regulation (EU) 2020/666	Implementing · Regulation	Published
Commission Implementing Decision (EU) 2020/437	Implementing · Decision	Published	Q1 2020
Commission Implementing Decision (EU) 2017/1445	Implementing · Decision	Published

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

Summary

Generated

Council Directive 93/42/EEC harmonizes EU rules for medical devices, requiring CE marking and conformity assessment before market placement. It applies to devices for diagnosis, prevention, monitoring, treatment, or alleviation of disease, excluding in vitro diagnostics and active implants. Devices are classified into four risk classes, with notified body involvement for higher classes.

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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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