Document reference

2012/0266(COD)  
Medical devices  
Basic information  

2012/0266(COD)

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

Repealing  Directives 90/385/EEC and 93/42/EEC 
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)

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

 

Key players  
Key events  
26/09/2012
Legislative proposal published
22/10/2012
Committee referral announced in Parliament, 1st reading/single reading
06/12/2012
Debate in Council
25/09/2013
Vote in committee, 1st reading/single reading
09/10/2013
Committee report tabled for plenary, 1st reading/single reading
22/10/2013
Results of vote in Parliament
22/10/2013
Debate in Parliament
22/10/2013
Decision by Parliament, 1st reading/single reading
09/12/2013
Debate in Council
02/04/2014
Decision by Parliament, 1st reading/single reading
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
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
04/04/2017
Debate in Parliament
05/04/2017
Decision by Parliament, 2nd reading
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

Repealing  Directives 90/385/EEC and 93/42/EEC 

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)

Legal basis
Treaty on the Functioning of the EU TFEU 114-p1; Treaty on the Functioning of the EU TFEU 168-p4
Mandatory consultation of other institutions
Stage reached in procedure
Procedure completed
Committee dossier
ENVI/8/06745
Documentation gateway  
  • European Parliament 
    Committee draft report
       
    12/04/2013
    EP
     
    Amendments tabled in committee
       
    14/05/2013
    EP
     
    Amendments tabled in committee
       
    14/05/2013
    EP
     
    Amendments tabled in committee
       
    14/05/2013
    EP
     
    Amendments tabled in committee
       
    14/05/2013
    EP
     
    Amendments tabled in committee
       
    PE510.851
    21/05/2013
    EP
     
    Committee opinion
    EMPL  
    20/06/2013
    EP
     
    Committee opinion
    IMCO  
    08/08/2013
    EP
     
    Committee report tabled for plenary, 1st reading/single reading
       
    09/10/2013
    EP
    Text adopted by Parliament, partial vote at 1st reading/single reading
       
    22/10/2013
    EP
    Text adopted by Parliament, 1st reading/single reading
       
    02/04/2014
    EP
    Committee draft report
       
    PE601.098
    15/03/2017
    EP
     
    Committee recommendation tabled for plenary, 2nd reading
       
    23/03/2017
    EP
    Text adopted by Parliament, 2nd reading
       
    05/04/2017
    EP
  • Council of the EU 
    Council statement on its position
     
    27/02/2017
    CSL
     
    Council position
     
    08/03/2017
    CSL
    Draft final act
     
    05/04/2017
    CSL
     
  • European Commission 
    Legislative proposal
     
    26/09/2012
    EC
    Document attached to the procedure
     
    26/09/2012
    EC
    Document attached to the procedure
     
    Eur-Lex link   SWD(2012)0273
    26/09/2012
    EC
     
    Document attached to the procedure
     
    Eur-Lex link   SWD(2012)0274
    26/09/2012
    EC
     
    Commission response to text adopted in plenary
     
    09/07/2014
     
     
    Commission communication on Council's position
     
    09/03/2017
    EC
  • National parliaments 
    Contribution
    IT_SENATE
    25/10/2012
    NP
     
  • Other institutions 
    Document attached to the procedure
     
    08/02/2013
    EDPS
    Economic and Social Committee: opinion, report
     
    14/02/2013
    ESC
     
  • All 
    Legislative proposal
       
    26/09/2012
    EC
    Document attached to the procedure
       
    26/09/2012
    EC
    Document attached to the procedure
       
    SWD(2012)0273 Eur-Lex link  
    26/09/2012
    EC
     
    Document attached to the procedure
       
    SWD(2012)0274 Eur-Lex link  
    26/09/2012
    EC
     
    Document attached to the procedure
       
    08/02/2013
    EDPS
    Economic and Social Committee: opinion, report
       
    14/02/2013
    ESC
     
    Committee draft report
       
    12/04/2013
    EP
     
    Amendments tabled in committee
       
    14/05/2013
    EP
     
    Amendments tabled in committee
       
    14/05/2013
    EP
     
    Amendments tabled in committee
       
    14/05/2013
    EP
     
    Amendments tabled in committee
       
    14/05/2013
    EP
     
    Amendments tabled in committee
       
    PE510.851
    21/05/2013
    EP
     
    Committee opinion
    EMPL  
    20/06/2013
    EP
     
    Committee opinion
    IMCO  
    08/08/2013
    EP
     
    Committee report tabled for plenary, 1st reading/single reading
       
    09/10/2013
    EP
    Text adopted by Parliament, partial vote at 1st reading/single reading
       
    22/10/2013
    EP
    Text adopted by Parliament, 1st reading/single reading
       
    02/04/2014
    EP
    Commission response to text adopted in plenary
       
    09/07/2014
     
     
    Council statement on its position
       
    27/02/2017
    CSL
     
    Council position
       
    08/03/2017
    CSL
    Commission communication on Council's position
       
    09/03/2017
    EC
    Committee draft report
       
    PE601.098
    15/03/2017
    EP
     
    Committee recommendation tabled for plenary, 2nd reading
       
    23/03/2017
    EP
    Text adopted by Parliament, 2nd reading
       
    05/04/2017
    EP
    Draft final act
       
    05/04/2017
    CSL
     
    Contribution
    IT_SENATE
    25/10/2012
    NP
     
Final act