EU MDR Transparency Not Enough: Time For A Big Debate?
Increased transparency is often highlighted as one of the major steps forward in the new EU Medical Device and IVD Regulations. But based on discussion at a Feb. 27 European Parliament committee meeting, some feel the changes do not go far enough. Is more debate needed?
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Nov. 25 was the halfway mark in the three-year transition toward full implementation of the new EU Medical Devices Regulation. It was also the day the International Consortium of Investigative Journalists (ICIJ) dropped a bomb on the medical device sector, and it has been shelling the industry every day since. How are key industry experts reacting?
The last year of the run up to the full implementation of the MDR has been characterized by a flurry of new documents and measures, but industry is adamant that medtech is heading for a crisis that will impact industry and patients alike.
With just a few months remaining until the full application of the EU Medical Device Regulation, notified body designations are still only trickling through. Ireland is the latest EU member state to have a resident MDR notified body.