2025/0404(COD)
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
Basic information
2025/0404(COD)
COD - Ordinary legislative procedure (ex-codecision procedure)
Regulation
Amending Regulation 2017/745
2012/0266(COD)
Amending Regulation 2017/746
2012/0267(COD)
Amending Regulation 2022/123
2020/0321(COD)
Amending Regulation 2024/1689
2021/0106(COD)
Subject
2.10.03 Standardisation, EC/EU standards and trade mark, certification, compliance
3.40.11 Precision engineering, optics, photography, medical
4.20.05 Health legislation and policy
4.60.08 Safety of products and services, product liability
Status
Awaiting committee decision
Key players
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European Parliament
Committee responsible Rapporteur Appointed SANTSCHENK Oliver (EPP)
13/02/2026
Committee for opinion Rapporteur for opinion Appointed GUZENINA Maria (S&D)
10/03/2026
Committee for budgetary assessment Rapporteur for budgetary assessment Appointed BUDGSOUSA SILVA Hélder (EPP)
08/04/2026
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European Commission
Commission DG Commissioner Health and Food Safety VÁRHELYI Olivér
Key events
| Date | Event | Reference | Summary |
|---|---|---|---|
| 16/12/2025 | Legislative proposal published | COM(2025)1023 | |
| 25/03/2026 | Committee referral announced in Parliament, 1st reading |
Technical information
| Procedure reference | 2025/0404(COD) |
|---|---|
| Procedure type | COD - Ordinary legislative procedure (ex-codecision procedure) |
| Procedure subtype | Legislation |
| Legislative instrument | Regulation |
| Amendments and repeals |
Amending Regulation 2017/745
2012/0266(COD)
Amending Regulation 2017/746 2012/0267(COD) Amending Regulation 2022/123 2020/0321(COD) Amending Regulation 2024/1689 2021/0106(COD) |
| Legal basis | Rules of Procedure EP 58 Treaty on the Functioning of the European Union TFEU 168-p4 Treaty on the Functioning of the European Union TFEU 114 |
| Mandatory consultation of other institutions | European Economic and Social Committee European Committee of the Regions |
| Stage reached in procedure | Awaiting committee decision |
| Committee dossier |
SANT/10/04839
|
Documentation gateway
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Document type Committee Reference Date Summary Committee draft report PE787.987 30/06/2026 -
Document type Reference Date Summary Legislative proposal COM(2025)1023 16/12/2025 Document attached to the procedure SWD(2025)1050 17/12/2025 Document attached to the procedure SWD(2025)1051 17/12/2025 Document attached to the procedure SWD(2025)1052 17/12/2025 -
Document type Parliament/Chamber Reference Date Summary Contribution IT_CHAMBER COM(2025)1023 27/04/2026 Reasoned opinion FR_SENATE PE789.077 01/06/2026 Contribution IT_SENATE COM(2025)1023 17/06/2026 -
Institution/body Document type Reference Date Summary EESC Economic and Social Committee: opinion, report CES4298/2025 29/04/2026
Additional information
Transparency
Meetings with interest representatives published in line with the Rules of Procedure
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Name Role Committee Date Interest representatives WÖLKEN Tiemo Shadow rapporteur SANT 15/07/2026 Association Mieux Prescrire PALMISANO Valentina Shadow rapporteur SANT 14/07/2026 Acumen Public Affairs WÖLKEN Tiemo Shadow rapporteur SANT 13/07/2026 MedicalMountains GmbH WÖLKEN Tiemo Shadow rapporteur SANT 03/07/2026 EUROMCONTACT WÖLKEN Tiemo Shadow rapporteur SANT 03/07/2026 Association of Medical Device Reprocessors WÖLKEN Tiemo Shadow rapporteur SANT 03/07/2026 Confindustria Dispositivi Medici GUZENINA Maria Rapporteur for opinion IMCO 02/07/2026 Standing Committee of European Doctors GUZENINA Maria Rapporteur for opinion IMCO 01/07/2026 Edwards Lifesciences GLÜCK Andreas Shadow rapporteur SANT 29/06/2026 Deutsche Krankenhausgesellschaft e.V. NÍ MHURCHÚ Cynthia Shadow rapporteur for opinion IMCO 26/06/2026 Stryker
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Name Date Interest representatives NEGRESCU Victor 10/07/2026 MedTech Europe HADJIPANTELA Michalis 07/07/2026 MedTech Europe KELLEHER Billy 06/07/2026 Stryker POLFJÄRD Jessica 30/06/2026 Mölnlycke Health Care AB POLFJÄRD Jessica 30/06/2026 EDANA AISBL KNOTEK Ondřej 25/06/2026 Abbott CHASTEL Olivier 11/06/2026 The European Association of Medical Devices – Notified Bodies KNOTEK Ondřej 03/06/2026 European Patients’ Forum BOSSE Stine 07/05/2026 Mölnlycke Health Care AB STORM Kristoffer 05/05/2026 Confederation of Danish Industry