EUDAMED delay: A small change of plan, voluntary registrations in March 2021
In our earlier articles, we pointed out that the Medical Device move from DG GROW to DG SANTE was going to be a positive one. Today at the Council of Europe we saw the first example of this positivity. Commissioner Stella Kyriakides announced, among other things, the EC is going to put the Eudamed Actors module live before March 31st 2021 rather than the planned date of MDR application May 26th 2020, actor registration will be on a voluntary basis. This is still a positive move which we believe is driven by the new DG SANTE Eudamed management team.
Why is this as a positive move?
One of the greatest, time-sensitive, bottlenecks was always going to be actor registration. Under the initial March 2020 go-live plan, competent authorities (CA) were always going to be under severe pressure to complete validations. CA’s would have to complete an estimated 80, 000+ actor validations in just two months (March 26th – May 26th 2020). The CA’s were being given a thankless task and for no major reason. The unnecessary pressure on CA’s has now been alleviated. The decision to deploy the actor module in May 2020 and the voluntary actor registration removes this stressful bottleneck. I think it is a very clever move from the European Commission and DG SANTE.
What does this mean for all the economic operators (EO’s)?
The main benefit is the manufacturers, system/procedure pack producers, authorised representatives, and importers, will be able to register and receive their SRN well in advance of the May 2022 deadline. They will be under no pressure to get the SRN, required to be able to get their devices and vigilance issues registered in Eudamed. The EO’s will be able to register and wait with no time pressures, comfortable in the knowledge the CA’s are working on their registration validation.
This is even better news for the Non-EU manufacturers who were even more disadvantaged with the registration process. Non-EU manufacturers could not register until their authorised representative had completed their registration. A non-EU manufacturer has a double validation, firstly by their authorised representative and secondly by the CA. Non-EU manufacturers are another group who should be happy with the new DG SANTE decision.
The biggest Eudamed bottleneck has been removed by this May deployment decision. It will give the manufacturers their SRN a lot sooner than 2022, which allows them to proceed with their labelling designs and processes. Notified bodies should also be pleased as the manufacturers will be able to present their SRN’s.
We are expecting the EC and DG SANTE to continue with this new pragmatic approach by releasing more modules as and when they complete full and successful testing. This would be fantastic as it will reduce the big bang pain that May 2022 was going to inflict. This approach allows DG SANTE to comfortably manage the data deliveries and avoid the data deluge expected in 2022.