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
3.30.06 Information and communication technologies, digital technologies
3.40.06 Electronics, electrotechnical industries, ICT, robotics
4.60.06 Consumers' economic and legal interests
Status
Preparatory phase in Parliament
Key players
-
European Parliament
Committee responsible Rapporteur Appointed Pending final decision on the referral Committee for opinion Rapporteur for opinion Appointed Pending final decision on the referral Committee for budgetary assessment Rapporteur for budgetary assessment Appointed Pending final decision on the referral -
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 |
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 EU TFEU 168-p4 Treaty on the Functioning of the EU TFEU 114 |
| Mandatory consultation of other institutions | European Economic and Social Committee European Committee of the Regions |
| Stage reached in procedure | Preparatory phase in Parliament |
Documentation gateway
-
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
Additional information
| Source | Document | Date |
|---|---|---|
| European Commission | EUR-Lex |
Transparency
Meetings with interest representatives published in line with the Rules of Procedure
-
Name Date Interest representatives MOTREANU Dan-Ştefan 03/02/2026 Aboca S.p.a. Società Agricola WÖLKEN Tiemo 29/01/2026 COCIR WÖLKEN Tiemo 21/01/2026 Bundesverband Medizintechnologie
MedTech Europe
SPECTARIS Deutscher Industrieverband für Optik, Photonik, Analysen- und Medizintechnik e.V.GONZÁLEZ CASARES Nicolás 21/01/2026 MedTech Europe