Actor registration

A:

The Medical Devices Regulations have provisions (MDR Art 31{7}/IVDR Art 28{7}) requiring to have the PRRC data accessible to the public.

The PRRC contact details entered in EUDAMED should not be private, but professional/business details. (Use of functional mailboxes is allowed).

A:

You can find your pending Actor registration request(s) with their application ID, on My pending requests page.

If you have no actor registered yet, this page is your homepage when accessing EUDAMED.

If you are already associated to more than one actor registered, on the My Actors page, which is your first page when accessing EUDAMED, click on 'See my pending requests' (bottom left).

If you are already associated to only one actor registered, or you have already selected the actor you want to act on behalf, click on the link with your name (top right corner) and scroll down till the end of the page, click on “See my pending Requests”.

A:

No, there is no possibility to delete the link between a non-EU manufacturer and an importer. The link remains for traceability reasons. The end date tells you if the importer is still linked to the manufacturer or not anymore.

A:

Firstly, please ensure that you are in the production environment of EUDAMED, not the playground environment. You can easily identify the playground because the European Commission logo on the top of the page has a red banner across it stating "Play". If you are a non-EU manufacturer and your actor registration request is still in the state Submitted, you should contact the Authorised Representative you indicated in your actor registration request.

A:

Registered actors can be found on the public EUDAMED site.

A:

Yes, if your organisation has multiple roles, you need to submit separated actor registration requests because your organisation needs a unique Actor ID/SRN for each different actor role. View the Actor ID/SRN and Actor roles infographic for more information.

A:

The duplicate check is performed on certain fields (name, address, VAT, EORI) for each separate Actor type, so an Actor registering a second time with the same name and address but for another actor type will not be marked as duplicate.

The duplicate check is a warning. It does not prevent you from submitting an actor registration request, however if you have a duplicate warning and the request is not a duplicate, it is good practice to add a justification in the Any other information of significance for the Competent Authority field.

A:

You can find your application ID on My pending requests page.

If you have no actor registered yet, this page is your homepage when accessing EUDAMED.

If you are already associated to or more actors registered, on the My Actors page, which is your first page when accessing EUDAMED, click on See my pending Requests link (bottom left).

If you are associated to only one actor registered or you have already selected the actor you want to act on behalf, click on the link with your name (top right corner) and scroll down till the end of the page and click on See my pending Requests.

A:

Once the registration is submitted, no update is possible. We advise to contact the responsible Competent Authority (CA). The CA can reject the request with the reason Correction needed. You can then make the correction and resubmit the request.

A:

The EORI number (Economic Operators Registration and Identification number) is an identification number, unique in the customs territory of the European Union, assigned by a customs authority to an economic operator or to another person with a view to registration for the purposes of customs. It is used in all customs procedures when exchanging information with customs administrations.

A:

Only a Local actor administrator profile (LAA) can update the actor details. If you have the LAA profile, from your dashboard, go to the Tasks section & My Actor data and click on Manage your actor data link. From this page, you can create a new version of your actor data.

A:

The EORI, VAT and National Trade Register Number cannot be updated via the User interface and data exchange. However, it is possible to address the SANTE EUDAMED SUPPORT with a request to change one of these items. The request will be assessed, and possibly performed, on a case-by-case basis depending on the justification for such change.

A:

No. Only the initial actor registration request is validated, updates will be notified to the responsible competent authority but they do not need to be validated.

A:

Only a Local actor administrator (LAA) can update the actor notification emails. Click on your name on the top right of the screen to access the settings. You can update the email address for each module under Actor notification email addresses.

A:

After having logged in and reached the dashboard. Click on your name on the top right of the screen to access your user account. The bottom of this page contains two buttons - one to submit a new actor registration request and one to submit a new access request. Alongside these, you will see the link to access your pending requests.

A:

No. A user cannot belong to both a Notified Body and an economic operator at the same time.

A:

The user should enter the registered place, meaning the address of the legal entity.

A:

The authority responsible for the approval of non-EU SPPP's actor registration requests should be the authority of the area where the first system or procedure pack of that producer is to be placed on the market.

Please find more details here.