Lisa Bartakovics, Avery Dennison Medical
Are you ready for MDR? That question has weighed on medical device manufacturers ever since the European Union proposed stronger device regulations and requirements.
After MDR became law in May 2017, the industry had four years to transition and comply. It’s been more than a year since MDR’s May 26, 2021, application date, yet there still is uncertainty regarding compliance requirements due to the lack of guidance documents and individual interpretation.