The Commission, after consulting the MDCG, shall set up, maintain and manage the European database on medical devices (‘Eudamed’) in accordance with the conditions and detailed arrangements established by Articles 33 and 34 of Regulation (EU) 2017/745.
Déanfaidh an Coimisiún, tar éis dó dul i gcomhairle leis an GCFL, an bunachar sonraí Eorpach i ndáil le feistí leighis (“Eudamed”) a chur ar bun, a chothabháil agus a bhainistiú i gcomhréir leis na coinníollacha agus leis na socruithe mionsonraithe a bhunaítear le hAirteagal 33 agus le hAirteagal 34 de Rialachán (AE) 2017/745.