Actor Registration to EUDAMED shall be available from next Tuesday (1.12.2020), as communicated earlier on this Platform.
The European Commission now released a very useful document with Frequently Asked Questions (FAQs) on the Actor module of EUDAMED. Here below, we enlist few important aspects:
Who and when?
Economic operators (including manufacturers, system/procedure pack producers, AR and importers) established within the EU 27, Iceland, Liechtenstein and Norway will be able to submit actor registration requests in EUDAMED.
Non-EU manufacturers will be able to register only if their authorised representative is established within the EU 27, Iceland, Liechtenstein and Norway.
Economic operators from the UK, Switzerland and Turkey will only be able to submit actor registration requests in EUDAMED at a later stage, not from December 2020.
UK
As the UK country will not exist in EUDAMED yet and the UK national competent authorities will not be registered in EUDAMED, Economic operators (including manufacturers, SPP producers, AR and importers) established in the UK will not be able to submit actor registration requests in EUDAMED actor module for the time being. The situation will be updated according to future relation arrangements with the UK/Northern Ireland, but not before January 2021.
Switzerland
Swiss national competent authorities will not be registered in EUDAMED until the mutual recognition agreement with Switzerland is fully updated to MDR (and in due course IVDR/IVDR Eudamed provisions) therefore they will not have access to the actor module from December 2020.
Turkey
Turkish national competent authorities will not be registered in EUDAMED as long as the Customs Union Agreement with Turkey has not been upgraded to MDR (and in due course the IVDR/IVDR EUDAMED provisions), therefore they will not have access to the actor module from December 2020.
Which authority is the competent authority to validate the actor registration?
The CA that has to validate an EU Actor registration request is a CA where the economic operator is located. When entering an Actor registration request, the name of the manufacturer must match with the name placed on the device label and in official documents like the certificates and the technical documentation.
Is there a deadline?
There is no agreed timeline for validation, except that it should be done within the best delay.
Same legal entity, several SRNs?
Same organisation (same legal entity name + address) can apply for more than one actor role. However, an actor will have only one registration per actor role, not per organisation. I.e.: if an organisation is manufacturer and importer, it will mean two registrations (and two SRNs), one (and only one) for each actor role.
Which documents are needed to register to EUDAMED and receive the SRN?
All economic operators must upload a signed Declaration on information security responsibilities. The non-EU manufacturers must have an active mandate with an already registered authorised representative (having an SRN) and upload with the registration a Mandate Summary document.
How will the SRN be communicated to the requestor?
An email will notify the economic operator that the SRN has been issued. The SRN itself will not be in the notification email but available via a link to a EUDAMED page with the SRN value in the email.
Will the Manufacturer be able to see in the system the importers linked to him?
Yes, the Manufacturer can see the linked Importers on the actor detail page on the Restricted website. Also everyone will be able to see them on the public website.
When does an Economic operator have to declare the PRRC?
Only Manufacturers and Authorised Representatives need to declare at least one PRRC during their actor registration in EUDAMED. Additional PRRCs can be added afterwards.
Will the Commission provide technical support as from 1 December 2020 for the Actors module?
Yes, as from 1st December 2020 the application support will be available on SANTE-EUDAMED-SUPPORT@ec.europa.eu
For all Questions and Answers, please have a look at the EC FAQs also available in our Library of Documents – EUDAMED.
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