Proposal for a Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices 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 - Opinion on the application of the Principles of Subsidiarity and Proportionality

Contents

  1. Kerngegevens
  2. Text
  3. EU Monitor

1.

Kerngegevens

Document date 12-12-2012
Publication date 22-01-2013
Reference 17031/12
From Portuguese Parliament
To The President of the Council of the European Union
External link original PDF
Original document in PDF

2.

Text

COUNCIL OF Brussels, 12 December 2012

THE EUROPEAN UNION

Interinstitutional Files: 17031/12

2012/0266 (COD)1 2012/0267 (COD)2

PHARM 90 SAN 309 MI 796 COMPET 745 CODEC 2870 INST 731 PARLNAT 388

COVER NOTE

from: Portuguese Parliament

date of receipt: 27 November 2012 to: The President of the Council of the European Union

No Cion doc.: 14499/12 PHARM 72 SAN 216 MI 598 COMPET 599 CODEC 2312 -

COM(2012) 541 final3 14493/12 PHARM 71 SAN 215 MI 597 COMPET 600 CODEC 2305 - COM(2012) 542 final1

Subject: Proposal for a Regulation of the European Parliament and of the Council on

in vitro diagnostic medical devices

Proposal for a Regulation of the European Parliament and of the Council on

Medical devices, and amending Directive 2001/83/EC4, Regulation (EC)

No 178/2002 and Regulation (EC) No 1223/20095

  • - 
    Opinion on the application of the Principles of Subsidiarity and Proportionality

Delegations will find attached for information a copy of the above opinion 1 .

________________________

1 The translation can be found at the Interparliamentary EU information exchange site IPEX at

the following addresses: http://www.ipex.eu/IPEXL-WEB/dossier/document/COM20120541.do#dossier COD20120267 http://www.ipex.eu/IPEXL-WEB/dossier/document/COM20120542.do#dossier COD20120266

 
 
 
 

3.

EU Monitor

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  • 1. 
    Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance. )
     
  • 2. 
    COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT pursuant to Article 294(6) of the Treaty on the Functioning of the European Union concerning the position of the Council on the adoption of a Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices
     
  • 3. 
    Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance. )
     
  • 4. 
    Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use
     
  • 5. 
    Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (recast)