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.
Lotje Anna HoogervorstTimon H GeurkinkAnne LübbekeSergio BuccheriJohan A F KoekkoekMarina TorrePaola LaricchiutaPaul PiscoiAlma Becic PedersenChris P GaleJames A SmithAldo Pietro MaggioniStefan K JamesAlan G FraserRob R G H H NelissenPerla J Marang-van de MheenPublished in: International journal of health policy and management (2023)
European cardiovascular and orthopaedic device registries could improve their potential as data sources for regulatory purposes by reaching consensus on standardised reporting of structural and methodological characteristics to judge the quality of the evidence as well as outcomes.