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2012/0266(COD)

Medical devices

Basic information

2012/0266(COD)

COD - Ordinary legislative procedure (ex-codecision procedure)

Regulation

Amending Directive 2001/83/EC 1999/0134(COD)
Amending Regulation (EC) No 178/2002 2000/0286(COD)
Amending Regulation (EC) No 1223/2009 2008/0035(COD)
See also 2012/0267(COD)
Amended by 2020/0060(COD)
Amended by 2022/0417(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.

Key players

Key events

Date Event Reference Summary
26/09/2012 Legislative proposal published COM(2012)0542
22/10/2012 Committee referral announced in Parliament, 1st reading
06/12/2012 Debate in Council
25/09/2013 Vote in committee, 1st reading
09/10/2013 Committee report tabled for plenary, 1st reading A7-0324/2013
22/10/2013 Decision by Parliament, 1st reading T7-0428/2013
22/10/2013 Results of vote in Parliament
22/10/2013 Debate in Parliament
09/12/2013 Debate in Council
02/04/2014 Decision by Parliament, 1st reading T7-0266/2014
02/04/2014 Results of vote in Parliament
19/06/2014 Debate in Council
05/11/2014 Committee decision to open interinstitutional negotiations after 1st reading in Parliament
01/12/2014 Debate in Council
16/06/2016 Debate in Council
20/09/2016 Debate in Council
08/03/2017 Council position published 10728/4/2016
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 A8-0068/2017
04/04/2017 Debate in Parliament
05/04/2017 Decision by Parliament, 1st reading T8-0107/2017
05/04/2017 Results of vote in Parliament
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 2012/0266(COD)
Procedure type COD - Ordinary legislative procedure (ex-codecision procedure)
Procedure subtype Legislation
Legislative instrument Regulation
Amendments and repeals Amending Directive 2001/83/EC 1999/0134(COD)
Amending Regulation (EC) No 178/2002 2000/0286(COD)
Amending Regulation (EC) No 1223/2009 2008/0035(COD)
See also 2012/0267(COD)
Amended by 2020/0060(COD)
Amended by 2022/0417(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
Mandatory consultation of other institutions European Economic and Social Committee European Committee of the Regions
Stage reached in procedure Procedure completed
Committee dossier ENVI/8/06745

Documentation gateway

  • Document type Committee Reference Date Summary
    Committee draft report PE507.972 12/04/2013
    Amendments tabled in committee PE510.741 14/05/2013
    Amendments tabled in committee PE510.765 14/05/2013
    Amendments tabled in committee PE510.766 14/05/2013
    Amendments tabled in committee PE510.767 14/05/2013
    Committee opinion EMPL PE506.249 20/06/2013
    Committee opinion IMCO PE507.987 08/08/2013
    Committee report tabled for plenary, 1st reading/single reading A7-0324/2013 09/10/2013
    Text adopted by Parliament, partial vote at 1st reading/single reading T7-0428/2013 22/10/2013
    Text adopted by Parliament, 1st reading/single reading T7-0266/2014 02/04/2014
    Committee draft report PE601.098 15/03/2017
    Committee recommendation tabled for plenary, 2nd reading A8-0068/2017 23/03/2017
    Text adopted by Parliament, 2nd reading T8-0107/2017 05/04/2017
  • Document type Reference Date Summary
    Council statement on its position 06592/1/2017 27/02/2017
    Council position 10728/4/2016 08/03/2017
    Draft final act 00014/2017/LEX 05/04/2017
  • Document type Reference Date Summary
    Commission document (COM) COM(2012)0540 26/09/2012
    Legislative proposal COM(2012)0542 26/09/2012
    Document attached to the procedure SWD(2012)0273 26/09/2012
    Document attached to the procedure SWD(2012)0274 26/09/2012
    Commission response to text adopted in plenary SP(2014)471 09/07/2014
    Commission communication on Council's position COM(2017)0129 09/03/2017
    Follow-up document SWD(2024)0076 22/03/2024
    Follow-up document COM(2024)0560 29/11/2024
  • Document type Parliament/Chamber Reference Date Summary
    Contribution IT_SENATE COM(2012)0542 25/10/2012
  • Institution/body Document type Reference Date Summary
    EDPS Document attached to the procedure N7-0042/2014 OJ C 358 07.12.2013, p. 0010 08/02/2013
    EESC Economic and Social Committee: opinion, report CES2185/2012 14/02/2013

Additional information

Source Document Date
EP Research Service Briefing
EP Research Service Briefing
National parliaments IPEX
European Commission EUR-Lex

Final act

Delegated acts

Reference Subject
2025/2675(DEA) Examination of delegated act
2025/2763(DEA) Examination of delegated act
2023/2796(DEA) Examination of delegated act
2022/2986(DEA) Examination of delegated act