Functional Specifications for the European Database on Medical Devices (EUDAMED)

14 December 2022 – the European Commission published guidance on functional specifications for EUDAMED.

Article 34 of Regulation (EU) 2017/745 obliges the Commission to draw up the functional specifications for EUDAMED in collaboration with the MDCG. This document will also be a reference for the independent audit to be performed for verifying that Eudamed has achieved full functionality.

Read the pdf 
Copyright Widler & Schiemann AG 2022. All Rights Reserved. /