News Medtech Regulations Newsletter

Registration of economic operators and transparency in EUDAMED

Posted on 09.09.2020

As of 1 December 2020, economic operators acting on the field of medical devices (including in vitro diagnostic medical devices) can apply for a Single Registration Number already ahead of the Date of Application of the MDR (Regulation EU 2017/745) and IVDR (Regulation EU 2017/746). The European Commission has confirmed its readiness to deploy the actor registration module of the future EUDAMED database by this deadline. Manufacturers, authorised representatives, importers and system/procedure pack producers can choose to fulfil their MDR/IVDR obligation for actor registration in this central EUDAMED module or at national level. The related MDCG position paper includes a commitment of National Competent Authorities accepting the registration done through the EUDAMED Actor module as far as national law allows that. This means that they are pledged to avoid double registration of the same actor for the same role – one at the national level and another in EUDAMED. Registration is per role (e.g. as authorised representative and as importer if an actor holds these two separate roles). 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 new medical device regulations will bring an enhanced level of transparency and will provide access to relevant information on medical devices for the general public including healthcare professionals and patients. The European Commission issued a Fact Sheet that lists documents that will be accessible once the EUDAMED database is in place. A number of documents referenced in the fact sheet will be released independently of EUDAMED.