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Procedure 2012/0266/COD

COM (2012) 542: Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009

Adopted acts: 32017R0745

European Commission
The European Data Protection Supervisor
Economic and Social Committee
European Parliament
Council of the European Union
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Legal basis: Commission:
TFUE/art 114, art 168 par 4 pt c
;
TFEU/art 294 par 6

European Parliament:
TFEU/art 294 par 6

Council of the European Union:
TFEU/art 294 par 6
Procedure: Ordinary legislative procedure (COD)
Co-decision procedure (COD)
Type of file: Proposal for a Regulation
EuroVoc thesaurus: +marketing standard; medical device; quality standard; safety standard; medical diagnosis
Directory code: 15.20.30.00 Environment, consumers and health protection / Consumers / Protection of health and safety
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European Commission 26/09/2012 : Supplement
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Documents: SWD/2012/273/FINAL
CELEX number of the main document: 52012SC0273
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European Commission 26/09/2012 : Supplement
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Documents: SWD/2012/274/FINAL
CELEX number of the main document: 52012SC0274
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European Commission 26/09/2012 : Adoption by Commission
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Leading person: John DALLI
Leading service: Directorate-General for Health and Consumers
Decision mode: Oral procedure
Addressee: European Data Protection Supervisor
Addressee for formal act: European Parliament ; Council of the European Union
Addressee for mandatory consultation: European Economic and Social Committee
Addressee for optional consultation: European Committee of the Regions
Legal basis: TFUE/art 114, art 168 par 4 pt c
Procedure: Ordinary legislative procedure (COD)
Type of file: Proposal for a Regulation
Documents: COM/2012/542/FINAL
CSST/2012/14493
IP/2012/1011
CELEX number of the main document: 52012PC0542
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European Commission 27/09/2012 : Transmission to Parliament
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European Commission 27/09/2012 : Transmission to Council
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The European Data Protection Supervisor 08/02/2013 : Opinion of the European Data Protection Supervisor
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Documents: JO C/2013/358/10
CELEX number of the main document: 52013XX1207(01)
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Economic and Social Committee 14/02/2013 : European Economic and Social Committee opinion
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Decision mode: Majority
Rapporteur: Cveto STANTIC
Documents: CESE/2012/2185
JO C/2013/133/52
CELEX number of the main document: 52012AE2185
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European Parliament 22/10/2013 : EP opinion on 1st reading
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Decision: Sending to parliamentary committee
Rapporteur: Dagmar ROTH-BEHRENDT
Documents: A7/2013/324
JO C/2016/208/697
TA/2013/428/P7
CELEX number of the main document: 52013AP0428
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Council of the European Union 10/12/2013 : Discussions within the Council or its preparatory bodies
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European Parliament 02/04/2014 : EP opinion on 1st reading
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Decision: Approval with amendments
Rapporteur: Dagmar ROTH-BEHRENDT
Documents: A7/2013/324
JO C/2017/408/68
TA/2014/266/P7
CELEX number of the main document: 52014AP0266
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Council of the European Union 20/06/2014 : Discussions within the Council or its preparatory bodies
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European Commission 09/07/2014 : Commission position on EP amendments on 1st reading
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Decision: Partial agreement
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Council of the European Union 01/12/2014 : Discussions within the Council or its preparatory bodies
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Council of the European Union 19/06/2015 : Discussions within the Council or its preparatory bodies
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Documents: CS-PRES/2015/10088
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Council of the European Union 05/10/2015 : Discussions within the Council or its preparatory bodies
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Council of the European Union 04/12/2015 : Discussions within the Council or its preparatory bodies
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Procedure: Ordinary legislative procedure (COD)
Documents: ST 14215 2015 INIT
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Council of the European Union 31/05/2016 : Discussions within the Council or its preparatory bodies
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Council of the European Union 15/06/2016 : Discussions within the Council or its preparatory bodies
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Documents: ST 9364 2016 REV 3
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Council of the European Union 16/06/2016 : Discussions within the Council or its preparatory bodies
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Documents: ST 9490 2016 INIT
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Council of the European Union 27/06/2016 : Discussions within the Council or its preparatory bodies
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Documents: ST 10617 2016 INIT
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Council of the European Union 08/07/2016 : Discussions within the Council or its preparatory bodies
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Documents: ST 11004 2016 INIT
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Council of the European Union 08/08/2016 : Discussions within the Council or its preparatory bodies
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Documents: ST 10617 2016 REV 1
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Council of the European Union 09/08/2016 : Discussions within the Council or its preparatory bodies
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Documents: ST 11662 2016 INIT
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Council of the European Union 31/08/2016 : Discussions within the Council or its preparatory bodies
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Documents: ST 11662 2016 COR 1
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Council of the European Union 01/09/2016 : Discussions within the Council or its preparatory bodies
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Documents: ST 11661 2016 INIT
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Council of the European Union 12/09/2016 : Discussions within the Council or its preparatory bodies
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Documents: ST 11661 2016 REV 1
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Council of the European Union 14/09/2016 : Discussions within the Council or its preparatory bodies
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Council of the European Union 16/09/2016 : Discussions within the Council or its preparatory bodies
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Council of the European Union 24/09/2016 : Discussions within the Council or its preparatory bodies
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Council of the European Union 16/11/2016 : Discussions within the Council or its preparatory bodies
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Documents: ST 5207 2016 INIT
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Council of the European Union 22/02/2017 : Discussions within the Council or its preparatory bodies
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Council of the European Union 24/02/2017 : Discussions within the Council or its preparatory bodies
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Documents: ST 6592 2017 INIT
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Council of the European Union 27/02/2017 : Discussions within the Council or its preparatory bodies
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Council of the European Union 28/02/2017 : Discussions within the Council or its preparatory bodies
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Council of the European Union 06/03/2017 : Discussions within the Council or its preparatory bodies
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Documents: ST 10728 2016 REV 3
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Council of the European Union 07/03/2017 : Council’s position at 1st reading and statement of reasons
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Documents: ST 10728 2016 REV 4 ADD 1
CELEX number of the main document: 52017AG0002(01)
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European Commission 09/03/2017 : Adoption by Commission of its communication on Council’s position at 1st reading
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Leading person: Elżbieta BIEŃKOWSKA
Leading service: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs
Addressee for formal act: European Parliament ; Council of the European Union
Addressee for information: European Economic and Social Committee ; European Committee of the Regions ; European Data Protection Supervisor
Addressee for mandatory consultation: National parliaments
Legal basis: TFEU/art 294 par 6
Procedure: Co-decision procedure (COD)
Documents: COM/2017/129/FINAL
CELEX number of the main document: 52017PC0129
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Council of the European Union 10/03/2017 : Discussions within the Council or its preparatory bodies
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Procedure: Ordinary legislative procedure (COD)
Documents: ST 7192 2017 INIT
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European Parliament 16/03/2017 : Receipt by the Parliament of the Council’s position at 1st reading
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Council of the European Union 17/03/2017 : Discussions within the Council or its preparatory bodies
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Procedure: Ordinary legislative procedure (COD)
Documents: ST 7192 2017 COR 1
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Council of the European Union 05/04/2017 : Discussions within the Council or its preparatory bodies
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Documents: ST 7972 2017 INIT
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European Parliament 05/04/2017 : EP opinion on 2nd reading
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Decision: Approval without amendment
Rapporteur: Glenis WILLMOTT
Documents: A8/2017/68
TA/2017/107/P8
IP/2017/847
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European Parliament Council of the European Union 05/04/2017 : Signature by the President of the EP and by the President of the Council
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Legal basis: TFEU/art 294 par 6
Procedure: Ordinary legislative procedure (COD)
CELEX number of the main document: 32017R0745

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