On 1 December 2020 the European Commission has made available the Actor registration module.
It is the first of six EUDAMED modules.
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 and additional national requirements on registrations can therefore not be excluded.
Other useful information
- Actor module FAQs
- MDCG 2021-13 related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers subject to the obligations of Article 31 of Regulation on medical devices and Article 28 of Regulation on in vitro diagnostic medical devices
- MDCG 2020-15 position paper on the use of the EUDAMED Actor registration module and of the single registration number in the EU countries
- Guidance documents to assist stakeholders in implementing the medical devices regulations
Actor identifier / Single registration number
The Actor registration module enables economic operators to submit, by means of an actor registration request, the information necessary to obtain an actor identifier/single registration number (Actor ID/SRN).
The Actor ID/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 Actor ID/SRN of the economic operator to the national competent authority and transfers it to the requesting economic operator
- Infographic: Actor roles and Actor ID/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.
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
- Actor module business process - the machine–to-machine management will only be available once the UDI/Device module is available
- Actor module business rules
- AIM-business process - the first notified body local actor administrator will only be available once the certificate module is available
- AIM-business rules