The first module of EUDAMED on Actor registration to be launched in December
Posted on 05.11.2020
The European Commission has launched a new dedicated webpage for collecting all necessary information on actor registration in EUDAMED.
The registration platform will be open from 1 December 2020 when this first module of the future European Medical Device Database will be launched – you can access the Actor Registration User Guide. EU and non-EU Manufacturers, authorised representatives, importers and system/procedure pack producers acting on the field of medical devices (including in vitro diagnostic medical devices) can apply for single registration number (SRN) already ahead of the Date of Application of the MDR (Regulation EU 2017/745) and IVDR (Regulation EU 2017/746). Infographic: Actor roles and SRN, Actor registration request process.
The advantage of getting a Single Registration Number early is to include it in relevant regulatory documentation (such as the Declaration of Conformity, Technical Documentation, Certificates issued by a Notified Body and Certificate of Free Sale) without the need of updating them at a later stage as the SRN will remain stable. The SRN guarantees an EU-wide unique identification for economic operators (also outside of EUDAMED). The registration as an economic operator in EUDAMED is also a precondition to start using other modules of the database upon their availability (such as the one for UDI and Device registration).
It is still to be confirmed which Member States will accept the registration of an economic operator only in EUDAMED, and which will maintain parallel their current national registration process and platform.