EUDAMED actor registration module went live on 1st of December and the system already contains information on several Economic Operators, mainly Manufacturers and Authorised Representatives. While the registration remains voluntary for the time being, actors are encouraged to proceed with the registration activities and to use the Single Registration Number as stipulated in the regulations.
The main objective of the actor registration module is to collate and process information necessary to identify Economic Operators active on the European market. As such, the actor registration module forms a prerequisite for use of other EUDAMED modules, once they become available, and facilitates a secure way of accessing the electronic system.
The registration process in EUDAMED is presented in a Wizard form and the system is designed to highlight input errors, e.g. missing required field, which block the user from progressing to the next step.
EUDAMED actor registration asks for the following information:
- Actor Identification. The Economic Operator role and country are selected from a drop-down and organisation name is either selected or entered. Optional fields include VAT number, EORI (Economic Operators Registration and Identification) number and National Trade Register. EOs can also upload any company identification document. Actors are encouraged to provide this voluntary data as it adds to the duplicate check and facilitates data validation by the Competent Authority.
- Authorised Representative. This section is applicable to non-EU Manufacturers only. Details of the AR can by searched within the system by SRN or by country and name of the organisation. It’s also mandatory to provide validity dates for the AR mandate and to upload mandate summary document into EUDAMED. Template for the mandate summary is provided by the Commission and can be accessed on the EC actor module website.
- Actor Address.
- Contact Information. Contact details are divided for those visible only to Competent Authorities and those visible to the public. Email address is the minimum required, additional contact information, such as name, phone number or website link can be provided.
- Persons Responsible for Regulatory Compliance. PRRC requirement is relevant to Manufacturers and Authorised Representatives. Name, email, phone number and address are required. Optionally, there is an open field to describe for what given PRRC is responsible. EUDAMED allows for adding multiple regulatory persons.
- Local Actor Administrator. LAA name must be provided and it can be linked via the EU Login account. EUDAMED also requires upload of signed declaration on information security responsibilities. The LAA function can be outsourced to a 3rd party and the system requires to specify, whether that’s the case, along with details of the person acting on behalf of the Economic Operator.
- Competent Authority. Actor registration process ends with defining the Competent Authority which will validate given actor. Selections is made from a drop-down list, which is filtered by company country. Once selected, CA details are auto-populated. Any information that might be of significance to the Competent Authority can be provided in optional field for additional information.
Once all data is inputted, the registration can be saved and submitted. Submitted request receives an ID and its status can be viewed in the system.
Single Registration Number is a code used for identification of an Economic Operator. Each SRN is linked with a specific role, which means that companies with multiple roles, i.e. Manufacturer, Authorised Representative, Importer or System and Procedure Pack Producer, will have multiple SRNs.
The responsibility to assign SRNs to Economic Operators lies with the Member States and the SRN must be requested from the responsible Competent Authority. For Manufacturers located within the European Union, this is the CA of the Member State where they are located and for non-EU manufacturers, it’s the Competent Authority of the Member State where their Authorised Representative is based.
To receive a Single Registration Number, Economic Operator must submit actor registration request in EUDAMED by providing the EO details as laid out above and in alignment with part 1 of Annex VI of the regulations. This data is then subject to validation by the relevant Competent Authority. For non-EU Manufacturers, its Authorised Representative verifies the registration request before passing it to the national CA for assessment. If assessed with positive outcome, the Competent Authority obtains an SRN from EUDAMED and approves the issuing of it to the requesting actor. EUDAMED sends a notification to the requestor and the SRN can be viewed in the system.
The request can also be sent back for corrections or refused. If asked to correct, the EO re-submits the registration request to the CA after adjusting data. In case of refusal, for both the CA as well as the Authorised Representative when reviewing data for the non-EU Manufacturer they represent, EUDAMED requires to specify the reason and include a justification. Reason types are incomplete or incorrect, wrong CA and/or AR, duplicate, request not applicable or fraud suspected.
The actor module is also used for managing users and access rights across EUDAMED. The person who performs the actor registration automatically becomes Local Actor Administrator (LAA). Once the actor registration is complete, the LAA can access EUDAMED and start managing its user access requests.
A user request starts with specifying the actor, for which the profile is being set up. If known, SRN of that actor can be used to retrieve details; if not, role, country and organisation name will need to be inputted to find the relevant Economic Operator. The requestor then needs to specify if acting as a subcontractor and if so, company name and contact details must be provided. Multiple profiles can be selected per user. Each profile is associated with a specific set of rights and higher profiles include all rights of the lower ones.
LAA is the highest profile within EUDAMED and contains the rights of all the lower profiles. Local Actor Administrator manages actor’s user access, actor data and system notifications. The next profile is Local User Administrator (LUA). LUA can manage user access requests. Finally, a Viewer can enter the restricted site and view registered actors as well as own actor details, regardless of the status. The Commission strongly recommends having at least two Local Actor Administrators to act as a fail-save mechanism if one is unable to respond and while it’s possible to delegate any profile to a 3rd party user, the Commission highlights that at least one LAA should be part of the organisation’s structure rather than outsourced to be able to manage data in cases of loss or breach of contract with the subcontractor.
LAA, LUA and Viewer are relevant for all actors but there are also additional, actor-specific profiles. Verifier, applicable to Authorised Representative, can verify non-EU Manufacturer registration requests and verify or terminate associated mandates. Mandate Manager, profile relevant for a non-EU Manufacturer, can submit and manage mandates with its Authorised Representative. Linker, Importer-specific profile, can link Importers with non-EU Manufacturers. LAA and LUA profiles for Importer also allow management of the Importer-Manufacturer relationships.
Do you have any questions related to EUDAMED registration or need support in meeting the registration obligations? Qserve helps medical device companies with MDR compliance and offers standard as well as tailored trainings on EUDAMED – contact us to learn more.