A cura di:
Expamed è una iniziativa di supporto alla adozione del nuovo Regolamento Europeo 745 sui dispositivi medici e si inserisce nella elaborazione di norme tecniche e standard internazionali. Regulation (EU) 2017/745 on Medical Devices (MDR) and Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR) are aimed at ensuring that safe and performant medical devices are being placed on the EU market whilst supporting innovation. These regulations contain important improvements among which stricter control for high-risk devices via a new pre-market scrutiny mechanism, reinforcement of the rules on clinical evidence and increased transparency. To this end, they require the establishment of scientific bodies, namely expert panels, expert laboratories and EU Reference Laboratories (EURLs). Their roles, described in Article 106 of the MDR and Article 100 of the IVDR, are to provide the European Commission, Member States, notified bodies and manufactures with scientific and technical advice, contribute to guidance and other relevant documents, and to identify emerging issues of concern regarding medical devices and in vitro diagnostic medical devices. The first scientific body to be put in place are the expert panels; EURLs and expert laboratories will be established at a later stage.
Anni di svolgimento: 2020 – Presente
Record ID: 355