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Guidance Needed To Explain Scope Of MDR’s Confusing Clinical Investigations Clause

 
• By Amanda Maxwell

Article 61(5) of the EU’s Medical Device Regulation gives certain manufacturers an exemption from having to perform clinical investigations by demonstrating equivalence to other companies’ products. But to whom does it apply and who could actually make use of it? Dr. Maria Donawa explains why clarification is urgently needed.

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Under the current EU Medical Devices Directive (MDD), many companies could rely on a literature review rather than a clinical investigation to demonstrate compliance with clinical requirements. Although, over the years, the rules have become tighter.

The Medical Device Regulation (MDR), which fully applies on 26 May 2020, is much stricter in requiring clinical investigations for...

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