Transparency and coordination of information are two key concepts of MDR. To achieve this goal, the EUDAMED plays an essential role. As the date of application of MDR was postponed to 2021/05/26, a fully functional EUDAMED release was also postponed to 2022/05. The European Commission has set up a rolling plan on releasing EUDAMED’s six modules.
First off, actors registration module will be deployed on 1 December 2020, as mentioned in the position paper. Through the Actor registration module, all the economic operators should apply for Single Registration Number (SRN) for each for their role by submitting an actor’s registration request. The economic operators include manufacturers, authorized representatives, system/procedure pack producers and importers, but not distributors. Since SRN is a unique identification system, the economic operators should apply a SRN for each role they play. For example, a manufacturer-cum-importer establishment should apply SRNs, one for their manufacturer role, and another for their importer role.
The European Commission explains the details of this application process on this webpage. The economic operator should upload a signed “Declaration on information security responsibilities”. As for non-EU entities, they should submit the registration a “Mandate Summary document” via their authorized representative. National competent authority will review the request and generate an SRN after approval. SRN consists of country ISO2 code, actor role abbreviation, and 9 digits.
EUDAMED six modules’ expected launch time are as following:
．Actors registration module: by 2020/12/01
．UDI/Devices registration module: by 2021/05
．Notified Bodies and certificates module: by 2021/05
．Clinical Investigations and performance studies module: by 2022/05
．Vigilance and post-market surveillance module: by 2022/05
．Market surveillance module: by 2022/05
1. MDCG 2020-15 MDCG Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States
2. Medical Device - EUDAMED Overview
3. Medical Device - EUDAMED Actor registration module