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”

Document Type : Commentary

Author

Cochlear AG, Basel, Switzerland

Abstract

This commentary draws on findings from Hoogervorst et al1 to underscore the urgent need for internationally coordinated medical device registries, addressing the fragmentation and inconsistency currently limiting their utility in Europe. It advocates for registries governed by academic specialty societies to ensure scientific integrity, transparency, and clinical relevance. Such registries can significantly enhance post-market surveillance, support regulatory compliance and accelerate real-world evidence (RWE) generation. The importance of standardized data collection, regular outcome reporting, and contributor recognition to foster engagement and improve data quality is highlighted. By complementing randomized controlled trials (RCTs), registries can detect rare adverse events, inform clinical guidelines and drive innovation. Actionable recommendations for governance, data harmonization and interoperability are given, emphasizing that now is the time for academic societies to lead this transformation for the benefit of patients and healthcare systems globally.

Keywords

References

  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:34172/ijhpm.2023.7648
  2. de Steiger RN, Hang JR, Miller LN, Graves SE, Davidson DC. Five-year results of the ASR XL acetabular system and the ASR hip resurfacing system: an analysis from the Australian Orthopaedic Association National Joint Replacement Registry. J Bone Joint Surg Am. 2011;93(24):2287-2293. doi:2106/jbjs.J.01727
  3. Capodanno D, Gori T, Nef H, et al. Percutaneous coronary intervention with everolimus-eluting bioresorbable vascular scaffolds in routine clinical practice: early and midterm outcomes from the European multicentre GHOST-EU registry. EuroIntervention. 2015;10(10):1144-1153. doi:4244/EIJY14M07_11
  4. International Medical Device Regulators Forum (IMDRF). Principles of International System of Registries. 2016. http://www.imdrf.org/documents/documents.asp.
  5. Crea F. Novel mechanistic insights into ventricular arrhythmias and sudden death. Eur Heart J. 2022;43(12):1177-1180. doi:1093/eurheartj/ehac115
  6. Zannad F, Garcia AA, Anker SD, et al. Clinical outcome endpoints in heart failure trials: a European Society of Cardiology Heart Failure Association consensus document. Eur J Heart Fail. 2013;15(10):1082-1094. doi:1093/eurjhf/hft095
  7. International Society of Arthroplasty Registries (ISAR). International Prosthesis Benchmarking Guidance. 2018. http://www.isarhome.org.
  8. Lagerqvist B, James SK, Stenestrand U, Lindbäck J, Nilsson T, Wallentin L. Long-term outcomes with drug-eluting stents versus bare-metal stents in Sweden. N Engl J Med. 2007;356(10):1009-1019. doi:1056/NEJMoa067722
  9. Deere KC, Whitehouse MR, Porter M, Blom AW, Sayers A. Assessing the non-inferiority of prosthesis constructs used in hip replacement using data from the National Joint Registry of England, Wales, Northern Ireland and the Isle of Man: a benchmarking study. BMJ Open. 2019;9(4):e026685. doi:1136/bmjopen-2018-026685
  10. Klonoff DC, Gutierrez A, Fleming A, Kerr D. Real-world evidence should be used in regulatory decisions about new pharmaceutical and medical device products for diabetes. J Diabetes Sci Technol. 2019;13(6):995-1000. doi:1177/1932296819839996
  11. Tarricone R, Torbica A, Drummond M. Challenges in the Assessment of Medical Devices: The MedtecHTA Project. Health Econ. 2017;26 Suppl 1:5-12. doi:1002/hec.3469
  12. American College of Cardiology. NCDR® Investigator's Guide to Research (Version 2.0). 2022. https://cvquality.acc.org/docs/default-source/ncdr/research/investigators-guide-to-ncdr-research.pdf.
  13. Murakami A, Hirata Y, Motomura N, Miyata H, Iwanaka T, Takamoto S. The national clinical database as an initiative for quality improvement in Japan. Korean J Thorac Cardiovasc Surg. 2014;47(5):437-443. doi:5090/kjtcs.2014.47.5.437

Files

History

  • Received Date: 05 August 2025
  • Revised Date: 29 December 2025
  • Accepted Date: 04 January 2026
  • First Published Date: 03 February 2026
  • Published Date: 01 December 2026

Share

How to cite

Statistics