EU MDR: Notified Body Clinical Evidence Expectations Could Spell Trouble For Manufacturers

Detailed guidance documents aim to provide clarity on what constitutes “sufficient” clinical evidence under the ­new EU Medical Device Regulation. But a void remains between the MDR itself and what notified bodies expect, senior regulatory consultant Søren Underbjerg attests.

Expectations
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As team lead for clinical development and market access at Denmark’s Qmed Consulting, Underbjerg has hands-on experience in helping medtech and medical device companies to navigate the new EU MDR – and the many hurdles that come with it.

The EU MDR is a “good thing,” Underbjerg recently told Medtech Insight. Despite the challenges faced by manufacturers in adhering to the new rules, he is of the view that...

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