The first module of the EUDAMED (European Databank on Medical Devices ) is live as of 1st December of 2020. This will enable economic operators to get a Single Registration Number (SRN).
MDR Registration Requirements
As you know, Chapter III of the MDR EU 2017/45 deals with identification and traceability of medical devices including registration of economic operators and mostly relies on the functionality of EUDAMED. In short, EUDAMED is an IT System which will enable implementation of the regulation. But due to the known factors there have will be delays in the availability of the system compared to the original plans of EU Commission.
Parallel to the requirements given on Article 33 of MDR, EUDAMED will have 6 electronic systems (modules) and a public website. These modules are;
- Actors registration
- UDI/Devices registration
- Notified Bodies and Certificates
- Clinical Investigations and performance studies
- Vigilance and post-market surveillance
- Market Surveillance
As detailed on the MDCG position paper issued on August 2020, “On 30 October 2019, the Commission published a notice by which it concluded that the full functionality of EUDAMED requires the availability and full operation of all six modules in accordance with the technical specifications and confirmed by an audit as referred to in Article 34. The notice foresees the launch of a fully functional EUDAMED for May 2022. However, at its meeting of 12 March 2020 the MDCG agreed that the Commission makes available to Member States each EUDAMED module on a gradual basis as soon as it is operational.”
EUDAMED Single Registration Number Module (Actors Registration)
According to this decision the first module for single registration number of economic operators is functional as of 1st December 2020 .So, in line with Article 30, all economic operators including legal manufacturers, authorised representatives and importers are able to get their SRN. To get more detailed information on accessibility to this first module you can check the FAQ’s document . On the other hand the user guide which is available via the EUDAMED web page includes useful information about account creation and other steps.
As defined on the paragraph 2 of Article 31, the responsibility to assign SRNs to economic operators lies with the Member States (Competent Authorities). After having verified and validated the data entered by an economic operator, the competent authority will obtain an SRN from the actor registration module and issue it to the requesting legal manufacturer, authorised representative or importer.
The registration of legal manufacturers which are located outside EU will be performed by the authorised representative as defined on Article 11 (3) c . Therefore the designation of the authorised representative shall refer to the mandate of registration.