Document reference

2012/0267(COD)  
In vitro diagnostic medical devices  
Basic information  

2012/0267(COD)

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

Repealing Directive 98/79/EC 1995/0013(COD)
See also 2012/0266(COD)
Amended by 2021/0323(COD)
Amended by 2023/0005(COD)
Amended by 2024/0021(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.: Please go to Documentation gateway for any follow-up documents. 
Key players  
Key events  
26/09/2012
Legislative proposal published
COM(2012)0541 Eur-Lex link
22/10/2012
Committee referral announced in Parliament, 1st reading
06/12/2012
Debate in Council
3206
25/09/2013
Vote in committee, 1st reading
10/10/2013
Committee report tabled for plenary, 1st reading
A7-0327/2013
22/10/2013
Results of vote in Parliament
22/10/2013
Debate in Parliament
22/10/2013
Decision by Parliament, 1st reading
T7-0427/2013
09/12/2013
Debate in Council
3280
02/04/2014
Decision by Parliament, 1st reading
T7-0267/2014
19/06/2014
Debate in Council
3323
05/11/2014
Committee decision to open interinstitutional negotiations after 1st reading in Parliament
01/12/2014
Debate in Council
3351
16/06/2016
Debate in Council
3475
20/09/2016
Debate in Council
3484
08/03/2017
Council position published
10729/4/2016
16/03/2017
Committee referral announced in Parliament, 2nd reading
21/03/2017
Vote in committee, 2nd reading
23/03/2017
Committee recommendation tabled for plenary, 2nd reading
A8-0069/2017
04/04/2017
Debate in Parliament
05/04/2017
Decision by Parliament, 2nd reading
T8-0108/2017
05/04/2017
Final act signed
05/04/2017
End of procedure in Parliament
05/05/2017
Final act published in Official Journal
Technical information  
Procedure reference
2012/0267(COD)
Procedure type
COD - Ordinary legislative procedure (ex-codecision procedure)
Procedure subtype
Legislation
Legislative instrument
Regulation

Repealing Directive 98/79/EC 1995/0013(COD)

See also 2012/0266(COD)

Amended by 2021/0323(COD)

Amended by 2023/0005(COD)

Amended by 2024/0021(COD)

Legal basis
Treaty on the Functioning of the EU TFEU 168-p4; Treaty on the Functioning of the EU TFEU 114-p1
Other legal basis
Rules of Procedure EP 165
Mandatory consultation of other institutions
European Economic and Social Committee European Committee of the Regions
Stage reached in procedure
Procedure completed
Committee dossier
ENVI/8/06746
Documentation gateway  
Final act  
Delegated acts  
2022/2985(DEA)  
Examination of delegated act