Medtech regulatory reform in the EU: Look to existing guidance documents and forget pre-market scrutiny
This article was originally published in SRA
Executive Summary
The European Commission's proposed introduction of a pre-market scrutiny procedure for medical devices signals that European regulators have lost faith in the wealth of EU and global guidance documents that have painstakingly been put together over the last decade. This very guidance, however, holds the key to future regulation, suggests Emmett Devereux.