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Making The Leap From EU MDD To MDR Clinical Evidence (Part 1): Practical Advice

 
• By Amanda Maxwell

Clinical evidence requirements are among the biggest challenges for manufacturers meeting the requirements of the EU’s new Medical Device Regulation. Maetrics’ Amie Smirthwaite explains how manufacturers should transition from the one to the other in part one of a three-part interview series with Medtech Insight.

Businessman reading documents with magnifying glass concept for analyzing a finance agreement or legal contract

When it comes to clinical evidence requirements under the Medical Device Regulation, the requirements are lengthy, and the wording may seem complicated to follow. It is an area constantly highlighted by industry, regulators and notified bodies as being both challenging and difficult to prepare for.

One key question that has generated a lot of attention is: what defines “sufficient” clinical evidence?

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