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How the new European regulation on medical devices will affect innovation

The European Union’s new regulatory framework for medical devices has central implications for the development of new devices, particularly by start-ups.

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Fig. 1: The patient-centric and user-centric approaches of the post-market regulatory cycle of the MDR for a high-risk medical device.


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Correspondence to Shiko M. Ben-Menahem.

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Ben-Menahem, S.M., Nistor-Gallo, R., Macia, G. et al. How the new European regulation on medical devices will affect innovation. Nat Biomed Eng 4, 585–590 (2020).

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