Dottorato in INGEGNERIA INDUSTRIALE E GESTIONALE

Titolo della tesi: Taxonomies of medical devices as a tool to support their monitoring and traceability in the Italian and international context: design and application to the Italian Implantable Prostheses Registry

In 2012, the European Commission highly encouraged a revision of medical device (MD) legislation in order not only to reinforce the post-market surveillance, but also to increase the vigilance, the functioning of notified bodies and the support to development useful tools, such as nomenclatures and registries, that might ensure patient safety, traceability and post-market surveillance of MDs. Thus, to ensure this action, the European Regulation 2017/745 (MDR) on medical devices was defined. The MDR stated the implementation of a European central MD database named EUDAMED to collect data on all MDs marketed in Europe in order to enhance transparency and better access to information for healthcare professionals. Following the MDR provisions, the adoption of an internationally recognised and free available MD nomenclature, the European Medical Device Nomenclature (EMDN), was required. On 4th March 2019, the EU Commission adopted the Italian National Classification of Medical Devices (CND) as a model. The CND nomenclature was introduced in Italy in 2007 by the Ministry of Health. MDs nomenclatures are also necessary to develop other systems having the need to classify MDs such as MDs registries. Article 108 of the MDR asks Member States to take measures to establish registries and databanks for specific types of medical devices to collect their information necessary for the evaluation of performance, traceability and long-term safety. To effectively monitor MDs, a registry should refer to a MD library, a database including all implantable devices collected by the registry and based on a MD taxonomy, classification or nomenclature. Each MD registered in the library is defined by a specific set of technical attributes. In Italy, the National Implantable Prostheses Registry (Registro nazionale delle protesi impiantabili, RIPI) was established to assess the effectiveness and safety of MDs belonging to the highest risk class. The aim of this Thesis is to describe the methodology used to design a taxonomy complementary to the existing nomenclature, as a tool to support monitoring and traceability of the devices included in RIPI (joint prostheses, spinal implants, cardiac implantable electronic devices, and hearing implantable devices).