Survey of Notified Bodies reveals very limited use of conditional certification for high-risk medical devices

Survey of Notified Bodies reveals very limited use of conditional certification for high-risk medical devices

The aim was to identify the experiences of Notified Bodies (NBs) in Europe in applying restrictions or limitations to certificates for high-risk medical devices. A survey examining NB practices regarding restrictions or limitations applied to Class III and IIb implantable medical devices was conduct...

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Bibliographic Details
Main Authors: A. Dobrzynska, J. C. Rejon-Parrilla, D. Epstein, J. Aranda-López, A. G. Fraser, J. A. Blasco-Amaro
Format: Article
Language:English
Published: Frontiers Media S.A. 2025-02-01
Series:Frontiers in Medical Technology
Subjects:
certificates of conformity
conditional approval
high-risk medical devices
Notified Bodies
Medical Device Regulation 2017/745
Online Access:https://www.frontiersin.org/articles/10.3389/fmedt.2025.1504294/full
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https://www.frontiersin.org/articles/10.3389/fmedt.2025.1504294/full

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