Actor registration module
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On 1st December 2020 the European Commission has made available the Actor registration module.
It is the first of six EUDAMED modules.
The European Commission, in agreement with the Medical Device Coordination Group (MDCG), is going to make available the different modules on a gradual basis as soon as they are functional.
The Commission is not in a position to require the use of the Actor registration module until EUDAMED is fully functional according to the Medical Device Regulation (MDR) and additional national requirements on registrations can therefore not be excluded.
A MDCG Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States was published in August 2020. MDCG 2020-15
FAQs
Single Registration Number – SRN
The Actor registration module enables economic operators to submit, by means of an actor registration request, the information necessary to obtain a single registration number (SRN).
The SRN guarantees a EU-wide unique identification for economic operators (also outside of EUDAMED).
- Following the assessment and approval of the request by the concerned national competent authority, EUDAMED generates the SRN of the economic operator to the national competent authority and transfers it to the requesting economic operator.
Infographic: Actor roles and SRN
Actor registration request process
Every economic operator - EU and non-EU manufacturers, authorised representatives, system/procedure pack producers and importers) has to register as an actor in EUDAMED and provide the required information.
- Infographic: Actor registration request process
- Video: Demo actor registration module
Documents to provide with the actor registration request
- Declaration on information security responsibilities
All actors must upload a signed Declaration on information security responsibilities (template in all EU languages) - Mandate Summary document
To register in EUDAMED, the non-EU manufacturers must have an active authorised representative and submit with the registration a Mandate Summary document
EUDAMED registered users
For an actor already registered in EUDAMED, all persons who intend to act on behalf of this actor need to enter an access request.
- Infographic: Users access requests
User guide for Economic Operators
Guide to using EUDAMED – Actor registration module for Economic Operators
Technical documentation
- Actor Module Business Process - the M2M management will only be available when the UDI/Device module will be made available
- Actor Module Business Rules
- AIM-Business Process - the first NB LAA will only be available when the certificate module will be made available
- AIM-Business Rules
Other useful information
- MDCG 2020-15 MDCG Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States
- Guidance documents to assist stakeholders in implementing the medical devices regulations.
| Disclaimer: The documentation in this page is subject to changes and updates whenever new information becomes available. |
Dernières mises à jour
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Publié01 Décembre 2020Sous: Medical Devices - Sector, Medical Devices - New regulations, Medical Devices - Topics of Interest, Medical Devices - Dialogue between interested parties, Medical Devices - Expert Panels, Medical Devices - EUDAMED
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