EU regulatory revision: Hype dying down – sense and seriousness can prevail
This article was originally published in Clinica
Executive Summary
It’s like a tightrope act for both the devices industry and the Brussels regulators: free market access for innovative, patient outcome-enhancing technology has to be balanced against patient safety. They want the optimum, most usable system, and that is what the European Commission is reaching for as it prepares to table its proposal for the new EU regulatory framework in late September.