Medical Devices Directive

PROPOSAL FOR A COUNCIL DIRECTIVE CONCERNING MEDICAL DEVICES

Stage: In force
Transposition deadline: 1 Jul 1994
Procedure: Directive
Last activity: 14 Jun 1993

2 acts

Delegated and implementing acts beneath it

By status: 2 published.

Act	Kind	Status	Adoption
Commission Delegated Directive (EU) 2017/1009	Implementing · Regulation	Published
Commission Delegated Regulation (EU) 2016/1387	Implementing · Decision	Published	Q1 2020

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.

What the workspace adds on this file

Everything above is the public record. Subscribers see this page with their own layer on top.

Why it matters to you

What this file means for your organization, assessed against your own priorities.

What moved

When this file moves, it reaches your own briefing, with a link to its source.

Your contacts on it

Your team's contacts logged against this file: who you met, what was said and the next step.

A first draft

A statement, a member update or a meeting brief on this file, in your organization's voice, with its sources.

Sources: EUR-Lex. Record as of 14 Sept 2026. Something wrong on this page? Report an error.

Request access

See this file with your own layer on top: why it matters to you, your contacts on it and a first draft. We’ll schedule a 20-minute walkthrough.

EU-hosted · GDPR-compliant · Trust Center →

By submitting, you agree to our privacy policy.