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

• Main Authors: Lotje A. Hoogervorst (Author), Timon H. Geurkink (Author), Anne Lübbeke (Author), Sergio Buccheri (Author), Jan W. Schoones (Author), Marina Torre (Author), Paola Laricchiuta (Author), Paul Piscoi (Author), Alma B. Pedersen (Author), Chris P. Gale (Author), James A. Smith (Author), Aldo P. Maggioni (Author), Stefan James (Author), Alan G. Fraser (Author), Rob G.H.H. Nelissen (Author), Perla J. Marang-van de Mheen (Author)
• Format: Book
• Published: Kerman University of Medical Sciences, 2023-12-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

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...