UK MHRA's Wilkinson questions practicalities of proposed EU scrutiny mechanism; Commission argues it is notified body measure
This article was originally published in Clinica
The medtech industry has been vocal in its reservations about the “scrutiny mechanism" advocated by the European Commission in its Medical Device Regulation (MDR) proposal. But it is not alone in its unease. The UK’s Medicine and Healthcare products Regulatory Agency (MHRA) also feels it needs to understand “much more” about how this would work in practice.