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

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

Background  The European Union Medical Device Regulation (MDR) requires manufacturers to undertake post-market clinical follow-up (PMCF) to assess the safety and performance of their devices following approval and Conformité Européenne (CE) marking. The quality and reliability of device registries f...

Full description

Bibliographic Details
Main Authors: Lotje A. Hoogervorst, Timon H. Geurkink, Anne Lübbeke, Sergio Buccheri, Jan W. Schoones, Marina Torre, Paola Laricchiuta, Paul Piscoi, Alma B. Pedersen, Chris P. Gale, James A. Smith, Aldo P. Maggioni, Stefan James, Alan G. Fraser, Rob G.H.H. Nelissen, Perla J. Marang-van de Mheen
Format: Article
Language:English
Published: Kerman University of Medical Sciences 2023-12-01
Series:International Journal of Health Policy and Management
Subjects:
medical device registries
cardiovascular
orthopaedic 
Online Access:https://www.ijhpm.com/article_4470_400ef7af971ca7e30d4a75dd339226a3.pdf

Internet

https://www.ijhpm.com/article_4470_400ef7af971ca7e30d4a75dd339226a3.pdf

Similar Items