Since 28 May 2026, the EUDAMED Economic Operators, Devices, Certificates and Market Surveillance modules have become mandatory. For a manufacturer established outside the European Union, the registration application must be accompanied by a summary of the mandate signed with the authorised representative, which must itself already be registered and hold its SRN.
Depending on the tasks covered by the mandate, the manufacturer may ask its authorised representative for support in completing the EUDAMED registration. That does not mean the representative creates or owns the manufacturer’s account. The non-EU manufacturer registers in EUDAMED as an economic actor in its own name. Its EC REP steps in to verify the application, confirm the mandate and enable its forwarding to the competent authority responsible for issuing the single registration number (SRN).
This allocation of roles must be understood from the outset. An imprecise arrangement can delay the SRN, the registration of devices and, ultimately, their placing on the European market.
Registration support is part of our EC REP mandate for manufacturers outside the European Union.
EUDAMED has been mandatory since 28 May 2026
The European Commission declared four EUDAMED modules functional through Decision (EU) 2025/2371, published on 27 November 2025. At the end of the six-month transition period provided for by Regulation (EU) 2024/1860, their use became mandatory on 28 May 2026.
The four modules concerned are:
- registration of economic operators;
- registration of devices (and their UDI);
- certificates;
- market surveillance.
For manufacturers, the first two are the most immediately operational. The manufacturer must first be registered as an actor and obtain its SRN before it can register its devices in the UDI/Devices module.
The Vigilance and post-market surveillance module, and the Clinical investigations and performance studies module, follow a separate timetable. The general obligation to use EUDAMED should therefore not be confused with the mandatory availability of all its functionalities.
The manufacturer keeps its own registration
A frequent mistake is to think that a non-EU manufacturer cannot create an EUDAMED account in its own name and that its authorised representative must carry out the whole process in its place.
What actually happens is different. The manufacturer registers as a “non-EU manufacturer” actor. It has its own workspace, its own users and, after validation, its own SRN. The authorised representative separately holds its EC REP registration and its own SRN.
The two actors are linked in EUDAMED by a mandate. That link allows the authorised representative to verify the manufacturer’s initial application and to confirm the generic device groups it represents.
The manufacturer’s SRN does not become the property of the authorised representative. Where the EC REP changes, the manufacturer in principle keeps its actor identity; it is the associated mandate and the information relating to the new representative that must be updated.
The prerequisites before submitting the application
A non-EU manufacturer cannot complete its registration without a valid EU authorised representative. Several elements must therefore be prepared upstream.
The manufacturer must in particular have:
- a written mandate accepted by the EC REP;
- the name and SRN of the authorised representative;
- an EU Login account linked to a professional email address;
- accurate legal information about its company;
- the contact details of its person responsible for regulatory compliance;
- a signed declaration on information security responsibilities;
- a summary of the mandate intended for EUDAMED.
The mandate summary must show in particular the names and addresses of the manufacturer and the authorised representative, the validity dates and the generic device groups covered. It does not replace the full mandate contract: it is a document specific to the EUDAMED process.
The information entered must be consistent with the regulatory documents. The manufacturer’s legal name must match the one appearing on the labelling, the certificates, the EU declaration of conformity and the technical documentation. Abbreviations, former company names and out-of-date addresses are frequent causes of correction requests.
The four steps to obtain an SRN as a non-EU manufacturer
1. Appoint an already registered authorised representative. The EC REP named in the application must itself be registered in EUDAMED. The manufacturer must therefore obtain its exact legal name and its SRN before starting.
At initial registration, the manufacturer selects an authorised representative from among those with which it holds a valid mandate. Where different representatives cover distinct generic device groups, the additional mandates can then be registered separately and must be verified by each EC REP concerned.
The contractual appointment must precede the EUDAMED application. A mere letter of intent or an ongoing negotiation is not enough to establish a valid mandate.
2. Submit the application as a non-EU manufacturer. The manufacturer creates its registration application in the EUDAMED production environment and selects the non-EU manufacturer role.
It enters the information about its organisation, its contacts, its PRRC and its authorised representative, then attaches the required documents. The user who submits the application normally becomes the first local actor administrator, or LAA, after validation.
This function should not be entrusted to an unmonitored generic email address or to someone likely to leave the company soon. The Commission recommends having at least two administrators, to avoid losing operational access to the account.
3. Have the application verified by the EC REP. After submission, the application is forwarded to the selected authorised representative. It does not issue the SRN and does not take the final decision. Its role is to verify the manufacturer’s information and the reality of the mandate.
The EC REP can:
- accept the application and forward it to the competent authority;
- ask the manufacturer for corrections;
- flag its disagreement in the comments sent to the authority.
This verification should not be treated as an automatic rubber stamp. The authorised representative engages its own regulatory responsibilities and must satisfy itself that the manufacturer identified in EUDAMED is indeed the entity it represents.
An application that stays in “Submitted” status is generally awaiting action by the authorised representative. The first party to contact is then the EC REP named in the application.
4. Wait for validation by the competent authority. Once verified by the authorised representative, the application is forwarded to the competent authority responsible for it. In France, this is the ANSM for the operators within its remit.
The authority examines the information and may approve the application, ask for corrections or refuse it. It alone carries out the final assessment.
After approval, EUDAMED generates the SRN and it is issued to the manufacturer by the competent authority. The manufacturer then receives a notification and can manage its profile, its users and its data in the database.
How long the process takes depends in particular on the quality of the application, the responsiveness of the EC REP and the authority’s workload. It is imprudent to treat obtaining the SRN as a formality that can be handled the day before a market launch.
Who then registers the devices?
Obtaining the SRN does not amount to registering the devices. These are two distinct steps.
The manufacturer must then register the required data in the Devices module, notably the Basic UDI-DIs, the UDI-DIs and the regulatory information relating to the devices concerned.
According to MDCG 2022-16, this obligation remains the manufacturer’s and cannot be transferred to the authorised representative. The EC REP may provide operational assistance if the contract so provides, but that assistance does not shift the regulatory responsibility.
For its part, the MDR requires the authorised representative to verify that the manufacturer has complied with its obligations relating to UDI and device registration. It must therefore have sufficient visibility of the registered data and of its consistency with the devices covered by its mandate.
The correct allocation can be summarised as follows:
- the manufacturer creates and maintains its actor and device data;
- the EC REP verifies the initial application, the mandates and compliance with the registration obligations;
- the competent authority validates the actor and issues the SRN;
- the notified body registers the information relating to its certificates;
- importers register separately and establish their links with the non-EU manufacturers concerned.
Keeping data and mandates up to date
EUDAMED is not a one-off enrolment. The information relating to the actor, its users, its devices and its mandates must remain accurate.
A change of company name, address, PRRC or contact details must be handled in accordance with the applicable regulatory deadlines. Article 31 of the MDR provides in particular for an update within one week when registered information changes. The accuracy of the data must also be confirmed periodically.
The same vigilance applies to mandates. Where the EC REP changes, the following must be coordinated:
- the end date of the outgoing mandate;
- the effective date of the new mandate;
- the update of the link in EUDAMED;
- the generic device groups covered;
- the update of the labelling and the EU declaration of conformity;
- the transfer of the relevant information and complaints.
EUDAMED does not replace the transition agreement provided for in Article 12 of the MDR. The database reflects the regulatory relationship, but does not organise it on its own.
The mistakes that most often block registration
Several mistakes recur regularly:
- starting the application before the EC REP is registered;
- selecting the wrong authorised representative or using an old SRN;
- entering a company name different from the one in the regulatory documents;
- attaching an incomplete or inconsistent mandate summary;
- appointing only one account administrator;
- believing that the SRN is enough to register the devices;
- delegating EUDAMED governance entirely to the authorised representative;
- forgetting to update the data after a change of PRRC or address.
The best prevention is to prepare a master data sheet jointly validated by the manufacturer and the EC REP before any data entry.
Key takeaways
The non-EU manufacturer registers in EUDAMED under its own identity and receives its own SRN. The EC REP does not substitute for it: it verifies the application, confirms the mandate and enables its forwarding to the competent authority.
After obtaining the SRN, the manufacturer remains responsible for registering its devices and keeping its data up to date. The authorised representative, for its part, must verify that these obligations have indeed been met.
EUDAMED makes this relationship more visible and more traceable. An imprecise mandate, inconsistent data or poorly defined account governance are no longer mere administrative weaknesses: they can concretely block access to the European market.