Development of a minimum checklist to assess the quality of evidence produced using registry data for the evaluation of medical device safety and performance

Objectives Medical device registries in Europe report limited information about their structure and methodological characteristics. This hinders their utility for evaluation of medical device safety and performance under the Medical Device Regulation. This study aimed to define a minimum checklist o...

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Principais autores:	Chris Wilkinson, David Erlinge, Stephan Windecker, Michael Dunbar, Gearoid McGauran, Frank Rademakers, Sergio Buccheri, Örjan Friberg, Rob Nelissen, Søren Overgaard, Timothy Wilton, Peter Vasko, Donal B O’Connor, Alma Becic Pedersen, Emil Hagström, David Epstein, Claudia Wild, Per Kjærsgaard-Andersen, Piotr Szymański, Stefan James, Marina Torre, Alan G. Fraser, Bart Pijls, Anne Lübbeke, Maziar Mohaddes, Tom Melvin, Lotje A. Hoogervorst, Rob G.H.H. Nelissen, Paul Piscoi, Chris P. Gale, Phil Walmsley, Robert E. Geertsma, Joëlle M. Hoebert, Perla J. Marang-van de Mheen, Christina Dimopoulou, Christoph Ziskoven, Elin Karlberg, Enrico Caiani, Enrique Gomez Barrena, Erman Melikyan, Filippo Boniforti, Fintan Bergin, Gavin Quigley, Gearoid O’Connor, Heather Prentice, Jantine van Baal, Juan Carlos RejónParrilla, Leo Hovestadt, Liza van Steenbergen, Nunung Nurrahmah, Paola Laricchiuta, Philip Walmsley, Ria Mahon, Richard Holborow, Roelf Postema, Stephen Dean
Formato:	Artigo
Idioma:	Inglês
Publicado:	BMJ Publishing Group 2025-10-01
Series:	BMJ Surgery, Interventions, & Health Technologies
Acceso en liña:	https://sit.bmj.com/content/7/1/e000364.full
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