Early compliance to the European Medical Device Regulation could give medical device manufacturers access to a potential $16.5 billion in revenues across the top 10 EU markets and Switzerland.
Nobody is in any doubt that the new European Medical Device Regulation (EU MDR) is on the agenda of compliance professionals in the medical devices industry. But is it far enough up on their priority list?
Early compliance to the European Medical Device Regulation—the outline of which was finally published in the Official Journal of the European Union on May 5, 2017—is crucial if manufacturers are to maintain access to EU markets, which in aggregate are economically larger than the United States.
The MDR replaces both the previous Medical Device Directive (93/42/ EEC) and the Active Implantable Medical Device Directive (90/385/EEC), and entails a raft of changes to the oversight of many critical processes in manufacturing (see sidebar "Key Issues for Compliance with the Medical Device Regulation (EU 2017/745)). Through a more transparent and comprehensive regulatory framework, the EU MDR is designed to improve clinical safety and fair market access for all medtech players while promoting innovation in the sector.