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Document 32017R0746
Procedure 2012/0267/COD
COM (2012) 541: Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on in vitro diagnostic medical devices
Completed (Adopted act: 32017R0746)
Type: Ordinary legislative procedure (COD)
- Legal basis:
Commission: TFUE/art 114, art 168 par 4 pt c; 12016E294-P6;- Type of file:
- Proposal for a Regulation
- EuroVoc thesaurus:
- marketing standard; medical device; quality standard
- Directory code:
- 15.20.30.00 Environment, consumers and health protection / Consumers / Protection of health and safety
-
European Parliament
-
Council of the European Union
-
European Commission
-
Economic and Social Committee
-
The European Data Protection Supervisor
/
Publication in the Official Journal
- Date of publication
- 05/05/2017
- CELEX number of the main document:
- 32017R0746
Signature
Signature by the President of the EP and by the President of the Council
05/04/2017
Second reading
27/06/2016
- Procedure:
- Ordinary legislative procedure (COD)
- Documents:
- ST 10618 2016 INIT
16/09/2016
- Procedure:
- Ordinary legislative procedure (COD)
- Documents:
- ST 11661 2016 REV 2
ST 11661 2016 REV 2 ADD 1
14/09/2016
- Procedure:
- Ordinary legislative procedure (COD)
- Documents:
- ST 11661 2016 REV 1 ADD 1
22/02/2017
- Procedure:
- Ordinary legislative procedure (COD)
- Documents:
- ST 10729 2016 ADD 1
ST 10729 2016 INIT
16/11/2016
- Procedure:
- Ordinary legislative procedure (COD)
- Documents:
- ST 11832 2016 INIT
ST 5207 2016 INIT
31/08/2016
- Procedure:
- Ordinary legislative procedure (COD)
- Documents:
- ST 10618 2016 REV 1
ST 11663 2016 INIT
08/07/2016
- Procedure:
- Ordinary legislative procedure (COD)
- Documents:
- ST 11004 2016 INIT
12/09/2016
- Procedure:
- Ordinary legislative procedure (COD)
- Documents:
- ST 11661 2016 REV 1
01/09/2016
- Procedure:
- Ordinary legislative procedure (COD)
- Documents:
- ST 11661 2016 INIT
24/02/2017
- Procedure:
- Ordinary legislative procedure (COD)
- Documents:
- ST 6593 2017 INIT
10/12/2013
- Documents:
- CS-PRES/2013/17546
CSST/2013/17583
28/02/2017
- Procedure:
- Ordinary legislative procedure (COD)
- Documents:
- ST 10729 2016 COR 2
ST 10729 2016 REV 2
ST 6593 2017 REV 1 ADD 1
27/02/2017
- Procedure:
- Ordinary legislative procedure (COD)
- Documents:
- ST 10729 2016 REV 1
05/10/2015
- Documents:
- CS-PRES/2015/12670
CSST/2015/12488
17/03/2017
- Procedure:
- Ordinary legislative procedure (COD)
- Documents:
- ST 7189 2017 COR 1
19/06/2015
- Documents:
- CS-PRES/2015/10088
10/03/2017
- Procedure:
- Ordinary legislative procedure (COD)
- Documents:
- ST 7189 2017 INIT
31/05/2016
- Procedure:
- Ordinary legislative procedure (COD)
- Documents:
- ST 9261 2016 INIT
ST 9262 2016 INIT
ST 9263 2016 INIT
05/04/2017
- Procedure:
- Ordinary legislative procedure (COD)
- Documents:
- ST 7974 2017 INIT
04/12/2015
- Procedure:
- Ordinary legislative procedure (COD)
- Documents:
- ST 14215 2015 INIT
20/06/2014
- Documents:
- CS-PRES/2014/11122
CSST/2014/11195
06/03/2017
- Procedure:
- Ordinary legislative procedure (COD)
- Documents:
- ST 10729 2016 REV 3
ST 6593 2017 REV 1 COR 1
01/03/2017
- Procedure:
- Ordinary legislative procedure (COD)
- Documents:
- ST 10729 2016 COR 3
01/12/2014
- Documents:
- CS-PRES/2014/16269
CSST/2014/16258/add 1
05/04/2017
- Decision:
- Approval without amendment
- Rapporteur:
- Peter LIESE
- Documents:
- A8/2017/69
TA/2017/108/P8
IP/2017/847
05/04/2017
- Parliamentary committee responsible
- Committee on the Environment, Public Health and Food Safety
- Rapporteur
- Peter LIESE
First reading
Receipt by the Parliament of the Council’s position at 1st reading
16/03/2017
EP decision on amendments to the legislative proposal
22/10/2013
EP position at first reading
02/04/2014
22/10/2013
- Decision:
- Sending to parliamentary committee
- Rapporteur:
- Peter LIESE
- Documents:
- A7/2013/327
JO C/2016/208/178
TA/2013/427/P7 - CELEX number of the main document:
- 52013AP0427
02/04/2014
- Decision:
- Approval with amendments
- Rapporteur:
- Peter LIESE
- Documents:
- A7/2013/327
JO C/2017/408/222
TA/2014/267/P7 - CELEX number of the main document:
- 52014AP0267
07/03/2017
- Council agenda:
- ITEM "A" ON COUNCIL AGENDA
- Council session:
- 3526
- Subject:
- General Affairs Council
- Procedure:
- Ordinary legislative procedure (COD)
- Documents:
- ST 10729 2016 REV 4
ST 10729 2016 REV 4 ADD 1 - CELEX number of the main document:
- 52017AG0003(01)
16/06/2016
- Procedure:
- Ordinary legislative procedure (COD)
- Documents:
- ST 9490 2016 INIT
15/06/2016
- Procedure:
- Ordinary legislative procedure (COD)
- Documents:
- ST 9365 2016 REV 2
ST 9365 2016 REV 3
09/03/2017
- 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:
- 12016E294-P6
- Procedure:
- Ordinary legislative procedure (COD)
- Documents:
- COM/2017/127/FINAL
- CELEX number of the main document:
- 52017PC0127
09/07/2014
- Decision:
- Partial agreement
Opinions
14/02/2013
- Decision mode:
- Majority
- Rapporteur:
- Cveto STANTIC
- Documents:
- CESE/2012/2185
JO C/2013/133/52 - CELEX number of the main document:
- 52012AE2185
Proposal
Transmission to Council
27/09/2012
26/09/2012
- Documents:
- SWD/2012/274/FINAL
- CELEX number of the main document:
- 52012SC0274
Transmission to Parliament
27/09/2012
26/09/2012
- Documents:
- SWD/2012/273/FINAL
- CELEX number of the main document:
- 52012SC0273
26/09/2012
- 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/2012/541/FINAL
CSST/2012/14499
IP/2012/1011 - CELEX number of the main document:
- 52012PC0541