EU Medical Device Regulation

Technological innovation is rapidly changing the healthcare industry. Mobile apps, wearable devices and digital interventions improve our understanding of patients. They accelerate diagnosis of chronic diseases, motivate positive lifestyle changes, enable more convenient care, and accelerates delivery of personalized medicine.

On May 26th, 2021, the new #EU Medical Device Regulation (MDR) was made applicable with ambitions to further enhance patient safety. With #MDR comes increased and stringent requirements for the development of medical devices including software as medical device (#SaMD) products. 

At Dawn Health we are proud to partner with Bech-Bruun on this exciting quality endeavor to support the public healthcare and life science industries in compliance with MDR. 

Holti Kellezi, Director of Business Development & Regulatory Affairs at Dawn Health, interviews Martin Dræbye Gantzhorn, Life Sciences & Healthcare Expert, Partner at Bech-Bruun in this Dawn Talks. The result is an insightful conversation that highlights the major differences between the old Medical Device Directive (MDD) and the new MDR.