Legislative Observatory
European Parliament
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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

Please go to Documentation gateway for any follow-up documents.

Key players

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

Forecasts

Date Subject
14/12/2026 Indicative plenary sitting date, 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

  • Document type Committee Reference Date Summary
    Committee draft report PE787.987 30/06/2026
    Amendments tabled in committee PE791.887 28/07/2026
    Amendments tabled in committee PE791.890 28/07/2026
    Amendments tabled in committee PE791.891 28/07/2026
  • 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

Source Document Date
European Parliament Briefing 10/03/2026
European Commission EUR-Lex

Transparency

Meetings with interest representatives published in line with the Rules of Procedure

  • Name Role Committee Date Interest representatives
    WÖLKEN Tiemo Shadow rapporteur SANT 21/10/2026 Koninklijke Philips
    WÖLKEN Tiemo Shadow rapporteur SANT 20/10/2026 AbbVie
    Abbott
    American Chamber of Commerce to the European Union
    Amgen Inc
    Bristol-Myers Squibb Company
    Eli Lilly and Company
    Illumina, Inc.
    Johnson & Johnson
    Pfizer Inc.
    Viatris
    WÖLKEN Tiemo Shadow rapporteur SANT 19/10/2026 European Society for Medical Oncology (ESMO)
    WÖLKEN Tiemo Shadow rapporteur SANT 19/10/2026 SMEunited aisbl
    WÖLKEN Tiemo Shadow rapporteur SANT 14/10/2026 Medical Device Manufacturers Association
    WÖLKEN Tiemo Shadow rapporteur SANT 13/10/2026 European Medicines Agency
    WÖLKEN Tiemo Shadow rapporteur SANT 13/10/2026 Edwards Lifesciences
    WÖLKEN Tiemo Shadow rapporteur SANT 12/10/2026 MedTech Europe
    GLÜCK Andreas Shadow rapporteur SANT 01/10/2026 Zimmer Biomet Holdings
    WÖLKEN Tiemo Shadow rapporteur SANT 01/10/2026 Implantcast