In 2017, the European Medical Device Regulation 2017/745 made official and effective the implementation of a unified European database on medical devices, EUDAMED, and stated the need to adopt a medical device (MD) nomenclature to support its functioning. Registries are a fundamental tool to evaluate MD long-term safety and to contribute to its traceability. To achieve these goals, the MD Library embedded in the Registry framework plays an important role as it contains all information useful to identify the implanted medical devices and to compare their performance. Similarly to EUDAMED, MD Registry Libraries are based on a detailed and defined MD taxonomy that allows a correct MD categorisation on the basis of a selected set of technical features. The aim of this study is to propose a generalised approach to build a MD taxonomy to be implemented in a MD Registry Library starting from the experience gathered in the implementation of the MD Registries included in the Italian Implantable Prostheses Registry (RIPI).
Key points to design the MDs Library of a National implant Registry: lesson learned from the Italian experience / Pascucci, S.; Franzo, M.; Mari, V.; Biondi, A.; Ceccarelli, S.; Bini, F.; Marinozzi, F.; Ciminello, E.; Ciccarelli, P.; Laricchiuta, P.; Carrani, E.; Torre, M.. - (2023). (Intervento presentato al convegno 8th National Congress of Bioengineering, GNB 2023 tenutosi a Padova).
Key points to design the MDs Library of a National implant Registry: lesson learned from the Italian experience
Pascucci S.;Franzo M.;Bini F.;Marinozzi F.;
2023
Abstract
In 2017, the European Medical Device Regulation 2017/745 made official and effective the implementation of a unified European database on medical devices, EUDAMED, and stated the need to adopt a medical device (MD) nomenclature to support its functioning. Registries are a fundamental tool to evaluate MD long-term safety and to contribute to its traceability. To achieve these goals, the MD Library embedded in the Registry framework plays an important role as it contains all information useful to identify the implanted medical devices and to compare their performance. Similarly to EUDAMED, MD Registry Libraries are based on a detailed and defined MD taxonomy that allows a correct MD categorisation on the basis of a selected set of technical features. The aim of this study is to propose a generalised approach to build a MD taxonomy to be implemented in a MD Registry Library starting from the experience gathered in the implementation of the MD Registries included in the Italian Implantable Prostheses Registry (RIPI).I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
