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

 
• By Eliza Slawther

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
• Source: Shutterstock

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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Commission’s Flora Giorgio Says Simplification And Safety Are Key In Evolving EU Regs

 
• By Amanda Maxwell

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More from Geography

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• By Brian Bossetta

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