Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions – Safe, effective and innovative medical devices and in vitro diagnostic medical devices for the benefit of patients, consumers and healthcare professionals

This Communication, together with two proposed Regulations to revise the European Union legislation on medical devices and in vitro diagnostic medical devices, constitutes a response to the Council Conclusions on innovation in the medical device sector adopted on 6 June 2011 and to the European Parliament Resolution on defective silicone breast implants adopted on 14 June 2012.

Related proposals:
- 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

• Primary Source

EUR-Lex: COM(2012)540: Follow the progress of this document through the decision-making procedure http://eur-lex.europa.eu/legal-content/EN/HIS/?uri=COM:2012:540:FIN

European Commission: COM(2012)541: Proposal for a Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2012:0541:FIN:EN:PDF

European Commission: 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 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2012:0542:FIN:EN:PDF

European Commission: SWD(2012)273: Impact assessment http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=SWD:2012:0273:FIN:EN:PDF

European Commission: SWD(2012)274: Summary of the impact assessment http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=SWD:2012:0274:FIN:EN:PDF

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