Dobrzynska A, Rejon-Parrilla J C, Epstein D, Aranda-López J, Fraser A G, Blasco-Amaro J A
Health Technology Assessment Area (AETSA), Andalusian Public Foundation Progress and Health (FPS), Seville, Spain.
Department of Applied Economics, University of Granada, Granada, Spain.
Front Med Technol. 2025 Feb 3;7:1504294. doi: 10.3389/fmedt.2025.1504294. eCollection 2025.
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.
目的是确定欧洲公告机构（NBs）在对高风险医疗器械证书施加限制方面的经验。作为“核心医疗器械（CORE-MD）2020地平线”项目的一部分，开展了一项调查，考察NBs对III类和IIb类植入式医疗器械施加限制的做法。13个NBs做出了回应；其中3个已颁发了带有限制条件的合格证书。NBs报告称在收集和提供有关有条件认证的数据方面存在挑战，这可能会增加其工作量。提高监管标准的清晰度、改善数据透明度、促进利益相关者的合作以及提供有针对性的培训，对于确保在欧盟范围内统一且一致地应用有条件认证至关重要。
