Everything you need to know about the EUDAMED actor registration module
The European Commission will make available the actor registration module to Member States and economic operators from December 1st, 2020. What do you need to know to be ready for it?
The actor registration module is the first of six EUDAMED (European Database on Medical Devices) modules to be released. It has been developed in accordance with Article 33 of Medical Devices Regulation (EU) 2017/745, also referred to as the MDR.
The main purpose of this module is to provide access to the database and assign each economic operator at least one unique identifier, the Single Registration Number (SRN), depending on their role(s). Economic operators will also be able to manage their actor information, user requests and different permissions. [1]
Actor roles
An actor is a natural or legal person (organisation) with a specific role that has to be registered in EUDAMED. The different actor roles in EUDAMED include both supervising entities, such as the European Commission, Competent Authorities and Notified Bodies; and economic operators.
There are four economic operator roles:
- Manufacturer (MF)
- Authorised Representative (AR)
- System & Procedure Pack Producer (PR)
- Importer (IM)
All economic operators must submit an actor registration request in order to receive a Single Registration Number (SRN).
The Single Registration Number
The actor registration module allows for the creation of a unique Single Registration Number (SRN). The SRN guarantees an EU-wide unique identification for economic operators (also outside of EUDAMED).
The SRN consists of 13 alphanumeric characters.
The economic operator will obtain a unique SRN for each actor role they fulfill. If the economic operator has multiple roles, separated registrations requests are required in order to obtain a different and specific SRN for each actor role. For example, a company that is a manufacturer and also system and procedure pack producer would need to submit two registrations and would be assigned two unique SRNs.
The responsibility to assign SRNs to economic operators lies with the Member States. After having verified and validated the information entered by an economic operator as part of the actor registration request, the competent authority of a Member State shall obtain an SRN from the database and approve the issuing of it to the requester.
The European Commission has published an infographic to clarify actor roles and Single Registration Number details [2].
Start using EUDAMED
To start using EUDAMED, it is required to have an EU Login account linked to a work email address. If there are no pending requests, the start page opens two different options: actor registration and new user access request.
Find further details about the step-by-step process in the Guide to using EUDAMED: actor registration module for economic operators [3].
What do I need to submit an actor registration request?
In order to submit an actor registration request, actors within the EU must provide a signed Declaration on information security responsibilities [4].
Additionally, non-EU economic operators that require an active authorised representative shall also submit a Mandate Summary document [5].
Keep in mind that manufacturers and authorised representatives need to declare at least one Person Responsible for Regulatory Compliance (PRRC) during their actor registration in EUDAMED. Additional PRRCs can be added afterwards.
Once the actor registration request is completed, apart from getting the SRN, the economic operator gets an active EUDAMED account and the person who requested the registration becomes the first Local Actor Administrator (LAA).
User requests and management
For an actor already registered in EUDAMED, all persons who intend to act on behalf of this actor need to enter an access request.
There are two main administrator user roles:
- Local Actor Administrator (LAA): Manages actor information and actor notification email addresses. Can also manage user access requests.
- Local User Administrator (LUA): Manages user access requests.
The European Commission recommends having at least two LAAs.
The second LAA and the LUAs have to be validated by the LAA. Any other user role with lower rights may be validated by both LAAs and LUAs.
The European Commission has published an infographic to clarify user access request and profile management [6].
Note that current registration is not mandatory until EUDAMED is fully functional in May 2022. However, the Medical Device Coordination Group (MDCG) recommends following a gradual implementation to ensure all requirements are met on time. Actors that obtain a SRN will be able to include it in relevant regulatory documentation (Declaration of Conformity, Technical Documentation, Certificates issued by a Notified Body and Certificate of Free Sale) without the need of updating them at a later stage as the SRN will remain stable. Moreover, they will have access to other early released modules, such as the devices and certificates modules, in the second quarter of 2021.
Are you ready for EUDAMED? Do not hesitate to contact us for support!
References and further information
[1]
[2]
Infographic – Eudamed actor roles and SRN
[3]
Guide to using EUDAMED actor registration module for economic operators
[4]
Declaration on information security responsibilities
[5]
Mandate Summary template for the registration in EUDAMED
[6]
Infographic – Eudamed user access request and profile management
[7]
Actor module Frequent Asked Questions
Irene Sanz Vizcaíno
