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European Commission proposes two new regulations on medical devices and in vitro diagnostic devices

01 October 2012

 
 
Medicines and Healthcare products Regulatory Agency (MHRA)

News release


On 26 September 2012, the European Commission proposed two new regulations on medical devices and in vitro diagnostic devices. This launches the European Union's (EU) legislative decision-making process; Member States and the European Parliament will examine, negotiate and agree on the final regulations, which will replace the existing three directives which regulate medical devices in the EU.

The Medicines and Healthcare products Regulatory Agency will hold a public consultation in October 2012 to gather analysis and evidence and seek views on the UK's draft negotiating position.

The European Commission's proposals and impact assessment are available below:



Further information