Regulatory readiness for innovation: a mixed-methods study of national competent authority professional and organizational capacities in the context of pre-market clinical investigations and early feasibility studies
There is significant variability in assessor qualifications and practices. These differences limit the consistency of regulatory oversight under the MDR. Establishing structured training programs, and harmonized sponsor dialogue mechanisms will be critical to supporting regulatory preparedness and coherence.
Authors
- Sebastian Kühn (ORCID: https://orcid.org/0000-0002-8031-2973)
- Nicolas Martelli (ORCID: https://orcid.org/0000-0001-5959-231X)
- Ornella Tangila Kayembe
- Francesco Malandrini (ORCID: https://orcid.org/0000-0002-0245-9849)
- Alexandra Herborg Cornelius Poulsson
- Majella Geraghty (ORCID: https://orcid.org/0009-0007-9596-410X)
- Tom Melvin
- Ali McDonnell
Institutions
- Norwegian Institute of Public Health (NO)
- Philipps University of Marburg (DE)
- Trinity College Dublin (IE)
- Assistance Publique – Hôpitaux de Paris (FR)
- Bocconi University (IT)
Publication Details
- Journal
- Expert Review of Medical Devices
- Published
- 2026-01-02
- DOI
- https://doi.org/10.1080/17434440.2025.2594460
- Citations
- 2
- Primary Topic
- Health Systems, Economic Evaluations, Quality of Life
- Type
- article
- Field-Weighted Citation Impact
- 199.62