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MDR Up-Classification Of Some Spinal Fusion Devices ‘Unwarranted’ Says Expert Group

 
• By Eliza Slawther

A change in risk classification for some legacy spinal fusion devices under the new EU MDR means that certain products face stricter clinical evidence requirements, which expert group OSMA told Medtech Insight is “unnecessary” and “overly-burdensome” for manufacturers.

Spine
• Source: Alamy

Experts from the Orthopaedic Surgical Manufacturers Association (OSMA) are concerned about the up-classification of some spinal fusion devices from class IIb under the former medical devices directive to class III under the new Medical Device Regulation, based on an interpretation of Rule 8 of the MDR by the guidance document MDCG 2021-24.

For some products, this up-classification has already resulted, or will result, in “significant burden, both administrative and evidentiary,” which is

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