Communication from the European Commission

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 the 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. Both the Council and the European Parliament have pointed to the necessity to adapt the medical device legislation to the needs of tomorrow with the aim to achieve a suitable, robust, transparent and sustainable regulatory framework. Such framework should be central to fostering the development of safe, effective and innovative medical devices and in vitro diagnostic medical devices, for the benefit of European patients, consumers and healthcare professionals.

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