Skip to main content
PolicySpeak
← All legislative files
Regulation (EU) 2024/18602024/0021(COD)COM(2024)43ENVI

Gradual roll-out of Eudamed, information obligation in case of interruption of supply and transitional provisions for certain in vitro diagnostic medical devices

Amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, information obligation in case of interruption of supply and the transitional provisions for certain in vitro diagnostic medical devices

Stage
In force, reached 9 Jul 2024
In force
In force since 9 Jul 2024 · CELEX 32024R1860
Procedure
Ordinary legislative procedure
Lead DG
DG SANTE
Commissioner
Stella Kyriakides
Last activity
21 Mar 2025
20 entries · record as of 14 Sept 2026

Where it stands

Latest: Public consultation closed: EU rules on medical devices and in vitro diagnostics - targeted evaluation, 332 responses, 21 Mar 2025.

Show the earlier record: 10 dates, 23 Jan 2024 to 23 Apr 2024
  1. 23 Jan 2024
    • Adoption of legislative proposal by the Commission
    • Discussions within the Council or its preparatory bodies
  2. 8 Feb 2024
    • Discussions within the Council or its preparatory bodies
  3. 14 Feb 2024
    • Adoption of negotiating mandate by Coreper
  4. 21 Feb 2024
    • Endorsement of the provisional agreement by Coreper
  5. 22 Feb 2024
    • Discussions within the Council or its preparatory bodies
  6. 26 Feb 2024
    • Referred to committee
  7. 21 Mar 2024
    • Discussions within the Council or its preparatory bodies
  8. 11 Apr 2024
    • Discussions within the Council or its preparatory bodies
  9. 12 Apr 2024
    • Discussions within the Council or its preparatory bodies
  10. 23 Apr 2024
    • Plenary vote
  1. 25 Apr 2024
    • Plenary adopted first-reading position
    • Plenary vote
  2. 29 Apr 2024
    • Discussions within the Council or its preparatory bodies
  3. 24 May 2024
    • Discussions within the Council or its preparatory bodies
  4. 28 May 2024
    • Discussions within the Council or its preparatory bodies
  5. 30 May 2024
    • Approval of the EP's first reading position by the Council (adoption of the legislative act)
  6. 13 Jun 2024
    • Signed
  7. 9 Jul 2024
    • Published in the Official Journal
  8. 21 Mar 2025
    • Public consultation closed: EU rules on medical devices and in vitro diagnostics - targeted evaluation, 332 responses · Commission
4 documents

Documents

Newest first. Each opens at its source.

Summary

Generated

This regulation amends EU medical device rules to implement a gradual, module-by-module activation of the Eudamed database, introduces a new obligation for manufacturers to notify authorities of supply interruptions for critical devices, and extends transitional deadlines for certain in vitro diagnostic devices.

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: EP Legislative Observatory · 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.