The new Medical Device Regulation (MDR) – the countdown is on
Europe’s new Medical Device Regulation (MDR) radically transforms the procedure medical device manufacturers and diagnostic companies must follow to launch their products on the European market. As well as that, manufacturers must maintain compliance throughout the product’s lifecycle. After a three-year transition period ending in May 2020, companies have to provide "sufficient clinical evidence" for the efficacy and safety of medical devices. For in vitro diagnostics, the transition period is five years, ending in May 2022. The new regulations will require clinical evaluation for many products which, until now, could acquire marketing authorisation solely on the basis of comparative studies with equivalent products. What’s more, the new regulation will enforce stricter rules for clinical data. SSS is well prepared for the new MDR and can support you in finding your strategy for the approval process.