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

Key players

Key events

Date Event Reference Summary
14/10/2021 Legislative proposal published COM(2021)0627
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

  • Document type Committee Reference Date Summary
    Text adopted by Parliament, 1st reading/single reading T9-0498/2021 15/12/2021
  • Document type Reference Date Summary
    Draft final act 00079/2021/LEX 25/01/2022
  • Document type Reference Date Summary
    Legislative proposal COM(2021)0627 14/10/2021
  • Document type Parliament/Chamber Reference Date Summary
    Contribution ES_PARLIAMENT COM(2021)0627 22/11/2021
  • Institution/body Document type Reference Date Summary
    ESC Economic and Social Committee: opinion, report CES5475/2021 08/12/2021