Document reference

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, awaiting publication in Official Journal

 

Key players  
Key events  
23/01/2024
Legislative proposal published
COM(2024)0043 Eur-Lex link
26/02/2024
Committee referral announced in Parliament, 1st reading
25/04/2024
Decision by Parliament, 1st reading
30/05/2024
Act adopted by Council after Parliament's 1st reading
13/06/2024
Final act signed
Technical information  
Procedure reference
2024/0021(COD)
Procedure type
COD - Ordinary legislative procedure (ex-codecision procedure)
Procedure subtype
Legislation
Legislative instrument
Regulation

Amending Regulation 2017/745 2012/0266(COD)

Amending Regulation 2017/746 2012/0267(COD)

Legal basis
Treaty on the Functioning of the EU TFEU 168-p4; Rules of Procedure EP 163; Treaty on the Functioning of the EU TFEU 114
Mandatory consultation of other institutions
Stage reached in procedure
Procedure completed, awaiting publication in Official Journal
Committee dossier
ENVI/9/14040
Documentation gateway  
  • European Parliament 
    Text adopted by Parliament, 1st reading/single reading
       
    25/04/2024
    EP
  • Council of the EU 
    Draft final act
     
    00054/2024/LEX
    13/06/2024
    CSL
     
  • European Commission 
    Legislative proposal
     
    COM(2024)0043 Eur-Lex link  
    23/01/2024
    EC
  • National parliaments 
    Contribution
    ES_PARLIAMENT
    09/04/2024
    NP
     
  • Other institutions 
    Economic and Social Committee: opinion, report
     
    20/03/2024
    ESC
     
  • All 
    Legislative proposal
       
    COM(2024)0043 Eur-Lex link  
    23/01/2024
    EC
    Economic and Social Committee: opinion, report
       
    20/03/2024
    ESC
     
    Text adopted by Parliament, 1st reading/single reading
       
    25/04/2024
    EP
    Draft final act
       
    00054/2024/LEX
    13/06/2024
    CSL
     
    Contribution
    ES_PARLIAMENT
    09/04/2024
    NP
     
Transparency  
Meetings with interest representatives published in line with the Rules of Procedure
  • Rapporteurs, Shadow Rapporteurs and Committee Chairs 
    Shadow rapporteur
    ENVI  
    22/02/2024
    Medical Mountains
    Shadow rapporteur
    ENVI  
    29/01/2024
    MedTech Europe
  • Other Members 
    18/03/2024
    Bundesverband Medizintechnologie
    04/03/2024
    Bundesverband Medizintechnologie
    22/02/2024
    Deutsche Sozialversicherung Europavertretung