UK Government Moves Closer to New System of Regulation for Medical Devices
The UK government has agreed with the recommendations made by a November 2012 report on the regulation of medical implants in the UK and EU issued by the House of Commons Science and Technology Committee, saying that an incremental approach to change is preferable to a complete overhaul.
The government notes in its response to the report that the proposed EU regulation on medical devices takes a similar incremental approach, although the European Commission (EC) did not take on board a number of recommendations from the Member States.
For example, the EC's proposal ignores a call for a Scientific Advisory Board, opting instead for the establishment of EU reference laboratories to provide scientific and technical assistance and advice to the notified bodies, Member States and the EC.
The UK Government response notes that it is reviewing whether the potential benefits of such laboratories may outweigh the costs that such entities would charge notified bodies for the scientific advice, given that any such additional costs would likely be passed onto device manufacturers.