Simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and support of the European Medicines Agency for the expert panels on medical devices and the list of Union harmonisation legislation
Amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and amending Regulation (EU) 2022/123 as regards the support of the European Medicines Agency for the expert panels on medical devices and Regulation (EU) 2024/1689 as regards the list of Union harmonisation legislation referred to in its Annex I
- Stage
- Committee report adopted, reached 30 Jun 2026
- Procedure
- Regulation · Ordinary legislative procedure
- Rapporteur
- Oliver Schenk (EPP)
- Lead DG
- DG SANTE
- Commissioner
- Olivér Várhelyi
- Last activity
- 10 Sept 2026
- Legal basis
- TFEU Art. 114; TFEU Art. 168; TFEU Art. 294
Where it stands
Latest: Deliberations in Council working party, 10 Sept 2026.
ShowHide the earlier record: 11 dates, 17 Dec 2025 to 30 Jun 2026
- 17 Dec 2025
- Adoption of legislative proposal by the Commission
- 23 Mar 2026
- Deliberations in Council working party · Council
- 25 Mar 2026
- Referral of the legislative proposal to the EP committee responsible (announced in plenary) · Parliament
- Referred to committee
- 21 Apr 2026
- Deliberations in Council working party · Council
- 7 May 2026
- Deliberations in Council working party · Council
- 21 May 2026
- Deliberations in Council working party · Council
- 28 May 2026
- Deliberations in Council working party · Council
- 3 Jun 2026
- Deliberations in Coreper · Council
- Deliberations in Council working party
- 5 Jun 2026
- Deliberations in Coreper
- 16 Jun 2026
- Deliberations in Council · Council
- 30 Jun 2026
- Committee report tabled
- EP committee draft report · Parliament committee
- 2 Jul 2026
- Deliberations in Council working party · Council
- 3 Jul 2026
- Deliberations in Council working party · Council
- 15 Jul 2026
- Deliberations in Council working party · Council
- 16 Jul 2026
- Deliberations in Council working party · Council
- 27 Jul 2026
- Deliberations in Council working party · Council
- 28 Jul 2026
- Committee amendments tabled
- Deliberations in Council working party · Council
- Tabling of amendments in the EP committee responsible
- 3 Aug 2026
- Feedback on adopted proposal closed: Targeted revision of the EU rules for medical devices and in vitro diagnostics , 293 responses · Commission
- 10 Sept 2026
- Deliberations in Council working party · Council
Who is on it
The Parliament's rapporteurs, shadow rapporteurs and opinion rapporteurs currently on this file.
| Role | Name | Group | Country | Committee |
|---|---|---|---|---|
| Rapporteur | Oliver Schenk | EPP | DE | SANT |
| Shadow rapporteur | Andreas GLÜCK | Renew | DE | SANT |
| Shadow rapporteur | Christine Anderson | ESN | DE | SANT |
| Shadow rapporteur | Ignazio Roberto Marino | Greens/EFA | IT | SANT |
| Shadow rapporteur | Laurent Castillo | PfE | FR | SANT |
| Shadow rapporteur | Ruggero Razza | ECR | IT | SANT |
| Shadow rapporteur | Tiemo Wölken | S&D | DE | SANT |
| Shadow rapporteur | Valentina Palmisano | The Left | IT | SANT |
| Rapporteur for opinion | Hélder Sousa Silva | EPP | PT | BUDG |
| Rapporteur for opinion | Maria Guzenina | S&D | FI | IMCO |
Amendments
Tabled on 8 Jul 2026. The texts are in the amendment documents below.
By committee
- IMCO201
By author
- Cynthia Ní Mhurchú38
- Henrik Dahl38
- Virginie Joron35
- Regina Doherty34
- Andreas Schwab29
- Christian Doleschal8
- Marlena Maląg7
- Maria Grapini5
- Arba Kokalari4
- Ernő SCHALLER-BAROSS2
- Maria Guzenina1
Amendments each member tabled or co-signed.
By article
- Article 1 – paragraph 1 – point 1511
- Article 1 – paragraph 1 – point 4411
- Article 4 – paragraph 1 – point 29
- Annex I – paragraph 1 – point 6 – point g8
- Article 1 – paragraph 1 – point 46
- Article 1 – paragraph 1 – point 2 – point e5
- Article 1 – paragraph 1 – point 34
- Article 1 – paragraph 1 – point 47 – point b4
- Article 1 – paragraph 1 – point 5 – point b4
- Article 1 – paragraph 1 – point 43 – point g3
ShowHide 20 more provisions
- Article 2 – paragraph 1 – point 33 – point b3
- Recital 233
- Recital 313
- Annex I – paragraph 1 – point 10 – point a2
- Annex I – paragraph 1 – point 12 – point b2
- Annex I – paragraph 1 – point 4 – point a2
- Annex I – paragraph 1 – point 7 – point c2
- Annex I – paragraph 1 – point 7 – point k a (new)2
- Annex II – paragraph 1 – point 1 – point d – point iii2
- Annex II – paragraph 1 – point 5 – point y2
- Annex II – paragraph 1 – point 6 – point a2
- Article 1 – paragraph 1 – point 10 – point b2
- Article 1 – paragraph 1 – point 14 – point b2
- Article 1 – paragraph 1 – point 212
- Article 1 – paragraph 1 – point 28 – point a2
- Article 1 – paragraph 1 – point 402
- Article 1 – paragraph 1 – point 43 – point d2
- Article 1 – paragraph 1 – point 47 – point a2
- Article 1 – paragraph 1 – point 5 – point a – point iii2
- Article 1 – paragraph 1 – point 5 – point b a (new)2
Covers 108 of the 201 amendments.
Documents
Newest first. Each opens at its source.
- Proposal · COM(2025)1023Commission · 16 Dec 2025
- Report · PE787.987Parliament
- Amendments · PE791.887Parliament
- Amendments · PE791.890Parliament
- Amendments · PE791.891Parliament
Consultations on it
The Commission's Have Your Say consultations linked to this file. Where we publish the positions filed, the title opens them here.
| Consultation | Feedback deadline | Feedback received |
|---|---|---|
| 3 Aug 2026 | 734 |
Summary
GeneratedThis regulation amends the EU medical devices and in vitro diagnostic medical devices regulations to simplify and reduce regulatory burden. It also strengthens the European Medicines Agency's support for expert panels on medical devices and updates the list of Union harmonisation legislation. The measure affects medical device manufacturers, health authorities, and the EMA.
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A first draft
Sources: EP Legislative Observatory · EU Law Tracker. Record as of 14 Sept 2026. Something wrong on this page? Report an error.
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