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Common Specifications: An Antidote To MDR’s Clinical Evidence ‘Moveable Feast’?

 
• By Eliza Slawther

Unpredictable clinical evidence expectations under the new EU medtech regulations can have a chilling effect on even the most established companies, resulting in product withdrawals. Medtech Insight asked a regulatory expert how this crisis can be avoided.

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• Source: Shutterstock

The EU Medical Device Regulation (MDR) poses several challenges for medtech companies, one of which is its clinical evidence requirements. While there is no quick fix to this problem, Tom Melvin, associate professor of Medical Device Regulatory Affairs at Trinity College, Dublin, suggested that the use of appropriate common specifications could provide much-needed clarity for companies.

Developing common specifications that describe the types of clinical evidence needed for various medical devices could help companies by setting out more predictable, clear requirements prior to applying for CE

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