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

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.

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Publication Details

Journal
International Journal of Health Policy and Management
Published
2026-02-03
DOI
https://doi.org/10.34172/ijhpm.9383
Primary Topic
Health Systems, Economic Evaluations, Quality of Life
Type
article
Field-Weighted Citation Impact
0.00
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article

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

Herbert Mauch
International Journal of Health Policy and Management
Health Systems, Economic Evaluations, Quality of Life
article

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

Herbert Mauch
article en

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.

International Journal of Health Policy and ManagementVol. 15
Cochlear (Switzerland) (CH)
Industry, innovation and infrastructure
Openalex Percentile: Top 37%
Health Systems, Economic Evaluations, Quality of Life
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