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
Status
Procedure completed
Key players
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European Parliament
Committee responsible Rapporteur Appointed Committee for opinion Rapporteur for opinion Appointed The committee decided not to give an opinion. -
European Commission
Commission DG Commissioner Health and Food Safety KYRIAKIDES Stella
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
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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