Medical device similarity analysis: a promising approach to medical device equivalence regulation
Traditionally, MDR equivalence involves manual review of many devices, which is laborious. However, our results suggest that the automated calculation of similarity coefficients streamlines this process, thus reducing regulatory effort, which can be beneficial for patients needing medical devices. Although this study is focused on the European perspective, it can find application within 510(k) equivalence regulation. The conceptual approach is reminiscent of chemical fingerprint similarity analysis employed in read-across.
Authors
- Joaquín Delgado Fernández (ORCID: https://orcid.org/0000-0003-1326-6134)
- Rupert Kellner (ORCID: https://orcid.org/0000-0002-6807-8731)
- Annette Bitsch (ORCID: https://orcid.org/0000-0003-1539-2871)
- Ulrich P. Froriep (ORCID: https://orcid.org/0000-0003-3313-6898)
- Theodor Doll (ORCID: https://orcid.org/0000-0001-8863-390X)
- Jan Sündermann (ORCID: https://orcid.org/0000-0002-8288-932X)
Institutions
- Medizinische Hochschule Hannover (DE)
- Fraunhofer Institute for Toxicology and Experimental Medicine (DE)
- Recherches Scientifiques Luxembourg (LU)
- Hearing4all (DE)
Publication Details
- Journal
- Expert Review of Medical Devices
- Published
- 2024-09-01
- DOI
- https://doi.org/10.1080/17434440.2024.2402027
- Citations
- 2
- Primary Topic
- Computational Drug Discovery Methods
- Type
- article
- Field-Weighted Citation Impact
- 0.72
Funders
- European Commission
- Horizon 2020