In this online exclusive, Paul Brooks, executive director, Regulatory Affairs Professionals Society (RAPS), looks at the impact Brexit may have on the healthcare product regulatory space and how clarity is urgently needed.
Brexit
The medical device sector is in a state of significant uncertainty. Preparations for the EU’s new Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) are creating challenges for regulatory professionals, and the uncertainty surrounding Brexit is equally problematic.