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POLICY BRIEF article

Front. Med. Technol.
Sec. Regulatory Affairs
Volume 7 - 2025 | doi: 10.3389/fmedt.2025.1504294

Survey of Notified Bodies Reveals very limited use of Conditional Certification for High-Risk Medical Devices

Provisionally accepted
Agnieszka Dobrzynska Agnieszka Dobrzynska 1*Juan Carlos Rejon-Parrilla Juan Carlos Rejon-Parrilla 1David Epstein David Epstein 2Juan Antonio Blasco- Amaro Juan Antonio Blasco- Amaro 1*Jesús Aranda Jesús Aranda 1Alan Fraser Alan Fraser 3,4
  • 1 Andalusian Public Foundation for Progress and Health, Junta de Andalucía, Sevilla, Spain
  • 2 University of Granada, Granada, Spain
  • 3 University Hospital of Wales, Cardiff, United Kingdom
  • 4 Department of Interventional Cardiology, University Hospital of Wales, Cardiff, United Kingdom

The final, formatted version of the article will be published soon.

    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.

    Keywords: Certificates of conformity, Conditional approval, High-risk medical devices, Notified bodies, Medical Device Regulation 2017/745

    Received: 30 Sep 2024; Accepted: 20 Jan 2025.

    Copyright: © 2025 Dobrzynska, Rejon-Parrilla, Epstein, Blasco- Amaro, Aranda and Fraser. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence:
    Agnieszka Dobrzynska, Andalusian Public Foundation for Progress and Health, Junta de Andalucía, Sevilla, Spain
    Juan Antonio Blasco- Amaro, Andalusian Public Foundation for Progress and Health, Junta de Andalucía, Sevilla, Spain

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.