Europe – MDCG 2021-1 : Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional

Article 33 of Regulation (EU) 2017/745 on medical devices1 (MDR) requires the Commission to set up a European database on medical devices (‘EUDAMED’). According to Article 33(2) of the MDR, Eudamed will be composed of six different electronic systems (so called ‘modules’), which facilitate the collation and processing of information under the MDR 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, vigilance and market surveillance as well as post-market surveillance…