Interview: MedTech Europe's Bernasconi Says Reg Complexities Warrant Longer Transition Period
Executive Summary
The near final texts of the Medical Devices and IVD Regulation texts are available, and the sector is champing at the bit to prepare for its new regulatory future. Yet there are many hurdles to cope with, especially because of challenges with notified bodies, and the current unpredictable regulatory environment. MedTech Europe’s Serge Bernasconi spoke to Medtech Insight about his views on why now is a particularly challenging time for companies operating in Europe.