UK MHRA builds on EU medtech reform plans with consultation
This article was originally published in SRA
Executive Summary
Do the proposals from the European Commission for reforming medtech regulation go far enough in promoting device safety and ensuring public confidence in the EU regulatory system? This is one of the questions that the UK’s Medicines and Healthcare products Regulatory Agency is asking in a 10-week public consultation on the proposals, citing the intense public debate surrounding PIP breast implants fraud and safety concerns involving metal-on-metal hips1,2.