On 18 August 2020, the European Commission’s Medical Devices Coordination Group (MDCG) published 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.
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. The notice foresees the launch of a fully functional EUDAMED for May 2022. However, it has been agreed by the MDCG that the Commission will make each EUDAMED module available to Member States on a gradual basis as soon as the module is operational.
The Commission has now confirmed its readiness to deploy the actor registration module as of 1 December 2020. This implies that from 1 December 2020 Medical Device and IVD manufacturers, authorised representatives, importers and system/procedure pack producers should be able to register in the actor registration module of EUDAMED. The actor registration module shall allow for the creation of a unique SRN. The responsibility to assign SRNs to economic operators lies with the Member States. After having verified and validated the data entered by an economic operator, the competent authority of a Member State shall obtain an SRN from the actor registration module and approve the issuing of it to the requesting manufacturer, authorised representative or importer.
What does this mean to you?
The MDCG “strongly encourages the use of the actor registration module by all relevant actors on their territories, including the use of the single registration number (SRN) by actors as stipulated in the MDR/IVDR.” This thus includes the use of the obtained SRN, e.g. on certificates or declarations of Conformity.
We strongly advise you to be prepared to register in the actor module and to obtain your SRN for each of the roles you will play under the MDR/IVDR once the module is released and to correctly apply the SRN on your documentation upon receiving your SRN(s).
Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.