EUDAMED – Actor registration: new Commission webpage with important guides & templates

The European Commission has launched a new webpage dedicated to the Actor registration module of EUDAMED, where it confirmed that the actor registration module will be available to Member States and economic operators from 1 December 2020.

The webpage also presents the links through which actor registration to EUDAMED will be performed, however those will become active from 1 December this year, as mentioned:

Moreover, the European Commission prepared several useful guidance documents on the Registration request process, e.g. info graphic on Actor registration request process & Users access request, Guide to using EUDAMED.

The Actor registration module will allow every economic operator – EU and non-EU manufacturers, authorised representatives, system/procedure pack producers and importers to fulfill the registration obligations as per the requirements of the upcoming Regulations.

Please note that there are certain documents that shall be submitted to EUDAMED when registering – templates below:

  1. Declaration on information security responsibilities

All actors must upload a signed version.

  1. Mandate Summary document

Non-EU manufacturers must have an active authorised representative and submit the above form.

Specifically, regarding the SRN (Single Registration Number allowing EU-wide identification of economic operators), please be informed that the Actor registration module will generate the SRN only after the request was assessed and approved by the concerned national competent authority.

Have a look at the new webpage, where you will find all the relevant information and documents on Actor registration.

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