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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Main Authors: | A. Dobrzynska, J. C. Rejon-Parrilla, D. Epstein, J. Aranda-López, A. G. Fraser, J. A. Blasco-Amaro |
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Format: | Article |
Language: | English |
Published: |
Frontiers Media S.A.
2025-02-01
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Series: | Frontiers in Medical Technology |
Subjects: | |
Online Access: | https://www.frontiersin.org/articles/10.3389/fmedt.2025.1504294/full |
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