UK Says More Transparency, Not Premarket Mechanism Needed for High-Risk Devices

January 23, 2013
In a response to the European Commission’s proposed overhaul of medical device regulations, the UK says more transparency is needed in clinical trials and approvals, but stops short of calling for increased premarket scrutiny of high-risk devices. According to a report published in December, UK lawmakers and regulators believe there is insufficient evidence for adopting a premarket mechanism akin to the premarket approval process in the U.S., and that the resulting delay in patient access to implants and high-risk devices would threaten patient safety.
International Medical Device Regulatory Monitor