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2024/0021(COD)

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

Basic information

2024/0021(COD)

COD - Ordinary legislative procedure (ex-codecision procedure)

Regulation

Amending Regulation 2017/745 2012/0266(COD)
Amending Regulation 2017/746 2012/0267(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

Procedure completed

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

Key players

Key events

Date Event Reference Summary
23/01/2024 Legislative proposal published COM(2024)0043
26/02/2024 Committee referral announced in Parliament, 1st reading
25/04/2024 Decision by Parliament, 1st reading T9-0368/2024
30/05/2024 Act adopted by Council after Parliament's 1st reading
13/06/2024 Final act signed
09/07/2024 Final act published in Official Journal

Technical information

Procedure Information
Procedure reference 2024/0021(COD)
Procedure type COD - Ordinary legislative procedure (ex-codecision procedure)
Nature of procedure Legislation
Legislative instrument Regulation
Amending Regulation 2017/745 2012/0266(COD)
Amending Regulation 2017/746 2012/0267(COD)
Legal basis Rules of Procedure EP 170 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 Procedure completed
Committee dossier ENVI/9/14040

Documentation gateway

  • Document type Committee Reference Date Summary
    Text adopted by Parliament, 1st reading/single reading T9-0368/2024 25/04/2024
  • Document type Reference Date Summary
    Draft final act 00054/2024/LEX 13/06/2024
  • Document type Reference Date Summary
    Legislative proposal COM(2024)0043 23/01/2024
  • Document type Parliament/Chamber Reference Date Summary
    Contribution ES_PARLIAMENT COM(2024)0043 09/04/2024
  • Institution/body Document type Reference Date Summary
    ESC Economic and Social Committee: opinion, report CES0746/2024 20/03/2024

Additional information

Source Document Date
EP Research Service Briefing 03/04/2024

Transparency

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

  • Name Role Committee Date Interest representatives
    WÖLKEN Tiemo Shadow rapporteur ENVI 22/02/2024 Medical Mountains
    WÖLKEN Tiemo Shadow rapporteur ENVI 29/01/2024 MedTech Europe
  • Name Date Interest representatives
    LIESE Peter 18/03/2024 Bundesverband Medizintechnologie
    LIESE Peter 04/03/2024 Bundesverband Medizintechnologie
    NIEBLER Angelika 22/02/2024 Deutsche Sozialversicherung Europavertretung

Final act