Harmonisation of medical devices classification systems: development of a generalised approach starting from hip prostheses. A first example of an international and standardised nomenclature to be integrated within the European Medical Device Nomenc
04 Pubblicazione in atti di convegno
Franzo' Michela, Carrani Eugenio, Asaro Mauro, Caton Edward, Tucker Keith, Armstrong Richard, Young Elaine, Sampaolo Letizia, Bini Fabiano, Marinozzi Franco, Torre Marina
Medical device (MD) nomenclatures are essential for
market surveillance and vigilance activities. Currently, more
than 25 arthroplasty Registries are established in Europe, each of
them based on a different MD nomenclature. A common and
shared nomenclature of orthopaedic implants is important to
analyse implant performance across different national databases
referring to a unique definition of its characteristics. Aim of this
study is to describe an approach to compare and harmonise two
different nomenclatures: a first step towards the organization of
an international nomenclature of medical devices