Article • The future of the EU Medical Device Regulation
Perfectly viable medical devices disappearing from the European market, manufacturers walking away from the EU rather than navigating regulatory demands, patients losing access to products with long, well-documented safety records. The implementation process for the MDR and IVDR has been challenging, to put it mildly – and the journey is far from over. Ahead of the EAAR’s MDR/IVDR Summit (European Association of Authorized Representatives) in Brussels, we spoke with EAAR Chair Ludger Möller about the current state of play, milestones ahead – and the role of AI in reshaping what a medical device even is.