Document reference

2021/0323(COD)  
Transitional provisions for certain in vitro diagnostic medical devices and deferred application of requirements for in-house devices  
Basic information  

2021/0323(COD)

COD - Ordinary legislative procedure (ex-codecision procedure)
Regulation

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

Legislative priorities
The EU’s response to the Covid-19 pandemic

Status

Procedure completed

 

Please go to Documentation gateway for any follow-up documents.: Please go to Documentation gateway for any follow-up documents. 
Key players  
Key events  
14/10/2021
Legislative proposal published
COM(2021)0627 Eur-Lex link
18/10/2021
Committee referral announced in Parliament, 1st reading
13/12/2021
Debate in Parliament
15/12/2021
Decision by Parliament, 1st reading
T9-0498/2021
20/12/2021
Act adopted by Council after Parliament's 1st reading
25/01/2022
Final act signed
28/01/2022
Final act published in Official Journal
Technical information  
Procedure reference
2021/0323(COD)
Procedure type
COD - Ordinary legislative procedure (ex-codecision procedure)
Procedure subtype
Legislation
Legislative instrument
Regulation

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/9/07442
Documentation gateway  
  • European Parliament 
    Text adopted by Parliament, 1st reading/single reading
       
    T9-0498/2021  
    15/12/2021
    EP
  • Council of the EU 
    Draft final act
     
    00079/2021/LEX
    25/01/2022
    CSL
     
  • European Commission 
    Legislative proposal
     
    COM(2021)0627   Eur-Lex link  
    14/10/2021
    EC
  • National parliaments 
    Contribution
    ES_PARLIAMENT
    COM(2021)0627  
    22/11/2021
    NP
     
  • Other institutions 
    Economic and Social Committee: opinion, report
     
    CES5475/2021  
    08/12/2021
    ESC
     
  • All 
    Legislative proposal
       
    COM(2021)0627   Eur-Lex link  
    14/10/2021
    EC
    Economic and Social Committee: opinion, report
       
    CES5475/2021  
    08/12/2021
    ESC
     
    Text adopted by Parliament, 1st reading/single reading
       
    T9-0498/2021  
    15/12/2021
    EP
    Draft final act
       
    00079/2021/LEX
    25/01/2022
    CSL
     
    Contribution
    ES_PARLIAMENT
    COM(2021)0627  
    22/11/2021
    NP
     
Final act