Following stories in the Daily Telegraph about their joint investigation with the British Medical Journal into the European regulatory system for medical devices, the MHRA have released the following statement:
An MHRA spokesperson said:
“We recognise that improvements to the regulation of medical devices need to be made. That’s why we fed into the European Commission’s review, specifically recommending improving the oversight of Notified Bodies, the improved surveillance of post-market events and the better collaboration between national regulatory bodies.
“The European Commission published their proposals on 26 September that includes many of the areas of improvement that the UK has been pushing for. We will shortly be consulting on the approach that the UK should take for negotiating the proposed legislation.”