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How the new European regulation on medical devices will affect innovation

Nature Biomedical Engineering volume 4, pages 585–590 (2020)Cite this article

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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.

References

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Author information

Authors and Affiliations

  1. Department of Management, Technology and Economics, ETH Zürich, Zurich, Switzerland

    Shiko M. Ben-Menahem & Georg von Krogh

  2. QMD Services GmbH, Vienna, Austria

    Raymond Nistor-Gallo

  3. F. Hoffmann-La Roche AG, Basel, Switzerland

    Gloria Macia

  4. Department of Health Sciences and Technology, ETH Zürich, Zurich, Switzerland

    Jörg Goldhahn

Authors
  1. Shiko M. Ben-Menahem
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  2. Raymond Nistor-Gallo
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  3. Gloria Macia
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  4. Georg von Krogh
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  5. Jörg Goldhahn
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Correspondence to Shiko M. Ben-Menahem.

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The authors declare no competing interests.

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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). https://doi.org/10.1038/s41551-020-0541-x

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