International Journal of Health Policy and Management

International Journal of Health Policy and Management

How to Make Medical Device Registry Data Fit for Purpose; A Response to Recent Commentaries

Articles in Press

Document Type : Correspondence

Authors
Lotje A. Hoogervorst 1
Rob G.H.H. Nelissen 1
Tom Melvin 2
Anne Lübbeke 3
Alan G. Fraser 4
Stefan James 5
Perla J. Marang van de Mheen 6
1 Department of Orthopaedics, Leiden University Medical Center, Leiden, The Netherlands
2 Trinity College Dublin, Dublin, Ireland
3 Division of Orthopaedic Surgery and Traumatology, Geneva University Hospitals and University of Geneva, Geneva, Switzerland
4 Department of Cardiology, University Hospital of Wales, Cardiff, UK
5 Department of Cardiology, Uppsala University, Uppsala, Sweden
6 Department of Safety & Security Science, Delft University of Technology, Delft, The Netherlands
Keywords
Medical Devices
Registries
Regulation

Three commentaries have recently been published in response to our manuscript “Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review.”1-4 ...(Read more...)

1.     Hoogervorst LA, Geurkink TH, Lübbeke A, et al. Quality and utility of European cardiovascular and orthopaedic registries for the regulatory evaluation of medical device safety and performance across the implant lifecycle: a systematic review. Int J Health Policy Manag. 2023;12:7648. doi:10.34172/ijhpm.2023.7648
2.     Mauch H. Advancing public health through internationally coordinated medical device registries: Comment on "Quality and utility of European cardiovascular and orthopaedic registries for the regulatory evaluation of medical device safety and performance across the implant lifecycle: a systematic review." Int J Health Policy Manag. 2026;15:9383. doi:10.34172/ijhpm.9383
3.     Holtzman JN, Redberg RF. From registry to reality: opportunities to enhance post-market surveillance of high-risk medical devices: Comment on "Quality and utility of European cardiovascular and orthopaedic registries for the regulatory evaluation of medical device safety and performance across the implant lifecycle: a systematic review.” Int J Health Policy Manag. 2025;14:9446. doi:10.34172/ijhpm.9446
4.     Alcalde-Herraiz M, Prieto-Alhambra D. Medical devices and real-world data: can we improve surveillance? Comment on “Quality and utility of European cardiovascular and orthopaedic registries for the regulatory evaluation of medical device safety and performance across the implant lifecycle: a systematic review.” Int J Health Policy Manag. 2026;15:9557. doi:10.34172/ijhpm.9557
5.     Hoogervorst LA, Nelissen RGHH, Melvin T, et al. Development of a minimum checklist to assess the quality of evidence produced using registry data for the evaluation of medical device safety and performance. BMJ Surg Interv Health Technol. 2025;7(1):e000364. doi:10.1136/bmjsit-2024-000364
6.     Lübbeke A, Hoogervorst LA, Marang-van de Mheen PJ, et al. Arthroplasty registries at a glance: an initiative of the International Society of Arthroplasty Registries (ISAR) to facilitate access, understanding, and reporting of registry data from an international perspective. Acta Orthop. 2025;96:116-126. doi:10.2340/17453674.2024.42706
7.     European Society of Cardiology. EuroHeart. https://www.escardio.org/data-science/data-collection/patient-registries-and-observational-data/euroheart/. Accessed July 2, 2026.
8.     Hoogervorst L, Nelissen RGHH, Van Steenbergen L, et al. Pooling data for primary total knee implants across national registries: is the same implant used in multiple registries and for the same patient group? An observational study. Acta Orthop. 2025;96:339-347. doi:10.2340/17453674.2025.43476
9.     Lübbeke A, Smith JA, Prieto-Alhambra D, Carr AJ. The case for an academic discipline of medical device science. EFORT Open Rev. 2021;6(3):160-163. doi:10.1302/2058-5241.6.200094
10. Hoogervorst LA, van Tilburg MM, Lübbeke A, Wilton T, Nelissen RGHH, Marang-van de Mheen PJ. Validating Orthopaedic Data Evaluation Panel (ODEP) ratings across 9 orthopaedic registries: total hip implants with an ODEP rating perform better than those without an ODEP rating. J Bone Joint Surg Am. 2024;106(17):1583-1593. doi:10.2106/JBJS.23.00793
11. Lübbeke A, Combescure C, Barea C, et al. Clinical investigations to evaluate high-risk orthopaedic devices: a systematic review of the peer-reviewed medical literature. EFORT Open Rev. 2023;8(11):781-791.  doi:10.1530/EOR-23-0024
12. European Commission. COM (2025) 1023. New Regulations. Simpler and more effective rules for medical devices – Commission proposal for a targeted revision of the medical devices regulations. https://eur-lex.europa.eu/procedure/EN/2025_404.  Accessed July 1, 2026.
13. Fink M, Jeiter T, Holborow R, Ziskoven C. Clinical evidence under the EU MDR: a notified body perspective. Regul Focus. 2023;3(4):24-31.
14. Fraser AG, Buccheri S, Byrne RA, et al. Recommended methodologies for clinical investigations of high-risk medical devices-Conclusions from the European Union CORE-MD Project. Lancet Reg Health Eur. 2025;58:101460. doi:10.1016/j.lanepe.2025.101460
15. Dobrzynska A, Rejon-Parrilla JC, Epstein D, Aranda-López J, Fraser AG, Blasco-Amaro JA. Survey of Notified Bodies reveals very limited use of conditional certification for high-risk medical devices. Front Med Technol. 2025;7:1504294. doi:10.3389/fmedt.2025.1504294
International Journal of Health Policy and Management

Articles in Press, Accepted Manuscript
Available Online from 22 July 2026

  • Received Date 09 July 2026
  • Accepted Date 11 July 2026
  • First Published Date 22 July 2026
  • Published Date 22 July 2026