Eudamed Actor Registration Module on track for December 2020
2020 has been a busy year for medical device companies trying to keep up-to-date with changes within the regulatory landscape. With Brexit looming and no ‘official’ confirmation of the way forward, it’s understandable if you have forgotten about Eudamed.
What is the latest with Eudamed?
In 2019, the European Commission announced a two-year delay for Eudamed. And then in August 2020, the MDCG published a position paper indicating the actor registration module would be ready in December 2020.
More recently, on 20th October 2020, the European Commission provided an update relating to the Eudamed actor registration module. And they’ve also given us a sneak peek into what is expected from 1st December 2020.
We suggest you have a look the following website:
To summarise the content on the website, the process for obtaining a Single Registration Number (SRN) has been clarified, including detail of the slightly different route for a non-EU manufacturer to obtain their SRN. There is also a rather exciting YouTube video demonstrating the Eudamed actor registration module. Furthermore, the website makes reference to two key documents that are required when a request for actor registration is made. These are the ‘Declaration on information security responsibilities’, this is relevant for all actors. And the ‘Mandate Summary document’ is required by non-EU manufacturers.
To top it off, a handy 60-page guidance document on using the Eudamed actor registration module has been produced. In addition, there are further details on the structures of user accounts relating to the Eudamed actor registration module. In brief, once an actor has obtained their SRN, the person who performed the registration becomes known as the ‘Local Actor Administrator (LAA)’. The LAA can permit additional user profiles being created to use the Eudamed actor registration module.
Will the module really be available from 1 December 2020?
There certainly has been a lot of date changing when considering both Eudamed and the MDR. However, it seems the estimated 1st December 2020 date for the first part of the implementation of Eudamed is accurate.
If you’re not quite sure of the requirements of Eudamed or require an extra hand preparing for the MDR or the IVDR, we would be happy to offer you support. Feel free to get in touch.
IMed QA/RA & MDR Consultant