Multiple guidance documents issued for Eudamed ‘Actor Registration’

The European Commission has published a number of guidance documents related to how manufacturers, authorised representatives and importers (‘economic operators’) will be able to access and register with the ‘actor registration’ module of Eudamed from 1 December 2020.

A new webpage has been set up within the Eudamed website, relating only to the actor registration module, with links to guidance documents and a video that takes you through the registration process (at high speed!). Some of the guidance documents include infographics which are aimed at simplifying the sometimes complex steps in the registration process, which are also described in a 60-page system user manual. Economic operators will need to carefully study the documents available from this webpage before attempting to register with Eudamed.

The actor registration module will be the first of six Eudamed modules to be available for use, with the remainder being phased in between now and the target completion date of May 2022. The Commission is urging economic operators to sign up with the module as soon as possible, because it provides each economic operator with its unique single registration number (SRN), which will be required for access to all of the other modules.

While the Medical Device Regulation (MDR, 2017/745) states that the whole of Eudamed must be fully functional before any of the modules ‘go live’, the Commission and all stakeholders have agreed to introduce them in phases, as described in MDCG 2020-15, to try and catch up with time lost during the two-year delay.