The first module of the European Commission’s Eudamed medical device database is set to go live by the beginning of December 2020, the Medical Device Coordination Group (MDCG) has confirmed.
Eudamed’s introduction was delayed by two years in October 2019, with the Commission concerned that it wouldn’t be ready for the initial target launch date of May 2020.
In March, the Commission and MDCG said that Eudamed’s six modules would go live on a rolling basis as they were made available. The actor registration module, the module due to go live in December, was initially predicted to be ready by March 2021, which has now been changed.
The module will allow device manufacturers, representatives, importers and pack producers to acquire the single registration number (SRN) required for certificates. MDCG has “strongly” encouraged all organisations to make full use of the module and SRN.
Regarding the regulatory implications of SRN, MDCG wrote: “Actors that obtain an SRN should be considered in compliance with the actor registration requirements … to the extent that national laws accommodate for this. In such cases, those actors should follow the obligations and requirements of the MDR related to both the registration of relevant actors (via the actor registration module) and the use of their SRN as required”.
Eudamed modules on device registration and certificates and notified bodies are due to go live in May 2021, with the Commission aiming to have the system ready in 2022.