Article 33 of Regulation (EU) 2017/745 on medical devices (MDR) and Article 30 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) requires the Commission to set up a European database on medical devices (‘Eudamed’). According to paragraph 2 of those Articles, Eudamed will be composed of six different electronic systems (so called ‘modules’), which facilitate the collation and processing of information under the MDR and IVDR regarding the registration of relevant economic operators (actor registration), devices and systems and procedure packs (UDI), notified bodies & certificates, certain aspects of conformity assessment, clinical investigations, performance studies, vigilance and market surveillance as well as post-market surveillance…
