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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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2025-02-01
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| Series: | Frontiers in Medical Technology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fmedt.2025.1504294/full |
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| author | A. Dobrzynska J. C. Rejon-Parrilla D. Epstein J. Aranda-López A. G. Fraser J. A. Blasco-Amaro |
| author_facet | A. Dobrzynska J. C. Rejon-Parrilla D. Epstein J. Aranda-López A. G. Fraser J. A. Blasco-Amaro |
| author_sort | A. Dobrzynska |
| collection | DOAJ |
| description | 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 conducted as part of the CORE-MD Horizon 2020 project. Thirteen NBs responded; three had issued certificates of conformity with restrictions or limitations. NBs reported challenges in collecting and providing data on conditional certification, which would likely increase their workload. Enhancing clarity of regulatory standards, improving data transparency, fostering stakeholders' collaboration, and providing targeted training are essential to ensure uniform and homogeneous application of conditional certifications across the EU. |
| format | Article |
| id | doaj-art-92db9e6b06ac4e8d9575cf26c47a9bd9 |
| institution | Kabale University |
| issn | 2673-3129 |
| language | English |
| publishDate | 2025-02-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Medical Technology |
| spelling | doaj-art-92db9e6b06ac4e8d9575cf26c47a9bd92025-02-03T06:33:27ZengFrontiers Media S.A.Frontiers in Medical Technology2673-31292025-02-01710.3389/fmedt.2025.15042941504294Survey of Notified Bodies reveals very limited use of conditional certification for high-risk medical devicesA. Dobrzynska0J. C. Rejon-Parrilla1D. Epstein2J. Aranda-López3A. G. Fraser4J. A. Blasco-Amaro5Health Technology Assessment Area (AETSA), Andalusian Public Foundation Progress and Health (FPS), Seville, SpainHealth Technology Assessment Area (AETSA), Andalusian Public Foundation Progress and Health (FPS), Seville, SpainDepartment of Applied Economics, University of Granada, Granada, SpainHealth Technology Assessment Area (AETSA), Andalusian Public Foundation Progress and Health (FPS), Seville, SpainDepartment of Cardiology, University Hospital of Wales, Cardiff, United KingdomHealth Technology Assessment Area (AETSA), Andalusian Public Foundation Progress and Health (FPS), Seville, SpainThe 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 conducted as part of the CORE-MD Horizon 2020 project. Thirteen NBs responded; three had issued certificates of conformity with restrictions or limitations. NBs reported challenges in collecting and providing data on conditional certification, which would likely increase their workload. Enhancing clarity of regulatory standards, improving data transparency, fostering stakeholders' collaboration, and providing targeted training are essential to ensure uniform and homogeneous application of conditional certifications across the EU.https://www.frontiersin.org/articles/10.3389/fmedt.2025.1504294/fullcertificates of conformityconditional approvalhigh-risk medical devicesNotified BodiesMedical Device Regulation 2017/745 |
| spellingShingle | A. Dobrzynska J. C. Rejon-Parrilla D. Epstein J. Aranda-López A. G. Fraser J. A. Blasco-Amaro Survey of Notified Bodies reveals very limited use of conditional certification for high-risk medical devices Frontiers in Medical Technology certificates of conformity conditional approval high-risk medical devices Notified Bodies Medical Device Regulation 2017/745 |
| title | Survey of Notified Bodies reveals very limited use of conditional certification for high-risk medical devices |
| title_full | Survey of Notified Bodies reveals very limited use of conditional certification for high-risk medical devices |
| title_fullStr | Survey of Notified Bodies reveals very limited use of conditional certification for high-risk medical devices |
| title_full_unstemmed | Survey of Notified Bodies reveals very limited use of conditional certification for high-risk medical devices |
| title_short | Survey of Notified Bodies reveals very limited use of conditional certification for high-risk medical devices |
| title_sort | survey of notified bodies reveals very limited use of conditional certification for high risk medical devices |
| topic | certificates of conformity conditional approval high-risk medical devices Notified Bodies Medical Device Regulation 2017/745 |
| url | https://www.frontiersin.org/articles/10.3389/fmedt.2025.1504294/full |
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