The value of using real-world evidence as a source of clinical evidence in the European medical device regulations: a mixed methods study-Reference-Cited by-同舟云学术

The value of using real-world evidence as a source of clinical evidence in the European medical device regulations: a mixed methods study

Published:2023-12-05 Issue:1-2 Volume:21 Page:149-163
ISSN:1743-4440
Container-title:Expert Review of Medical Devices
language:en
Short-container-title:Expert Review of Medical Devices

Author:

McDermott Olivia¹^ORCID,Kearney Breda¹

Affiliation:

1. College of Science & Engineering, University of Galway, Galway, Ireland

Funder

no funding associated with this research

Publisher

Informa UK Limited

Subject

Biomedical Engineering,General Medicine,Surgery

Link

https://www.tandfonline.com/doi/pdf/10.1080/17434440.2023.2291454

Reference55 articles.

1. MedTech Europe’s facts and figures 2021 [Internet];Europe M.;MedTech Europe,2021

2. Improving Medical Device Regulation: The United States and Europe in Perspective

3. Medical Device Coordination Group. Medical Device Coordination Group Working Groups [Internet]. 2021 [cited 2023 Jan 12]. Available from: https://health.ec.europa.eu/medical-devices-dialogue-between-interested-parties/medical-device-coordination-group-working-groups_en.

4. European Commission. New EU rules to ensure safety of medical devices [Internet]. European Commission - European Commission. 2017 [cited 2023 Jan 19]. Available from: https://ec.europa.eu/commission/presscorner/detail/et/MEMO_17_848.

5. New era in medical device regulations in the European union;Majety RPD;Pharm Regul Aff,2021

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