For a manufacturer established outside the European Union, changing EU authorised representative, or EC REP, is not a mere substitution of provider. The operation directly affects the manufacturer’s regulatory representation, its compliance documentation, labelling, European registrations and, where applicable, relations with the notified body.
A poorly prepared transition can lead to the absence of a valid mandate, documentary inconsistencies or a failure to handle complaints and incidents. It can then jeopardise the ability to continue placing the devices concerned on the market.
If you are considering a transition, see how we take over an existing EC REP mandate.
Why a change of EC REP must be prepared
Where a manufacturer is not established in a Member State, Article 11 of the MDR requires it to appoint a single authorised representative in the Union, at least for all devices belonging to the same generic device group. That appointment must be the subject of a written mandate accepted by the representative.
A distinction must nonetheless be drawn between placing new devices on the market and the situation of units already lawfully placed on the market. To claim that all “marketing” automatically becomes illegal as soon as the mandate ends would be too sweeping. On the other hand, a non-EU manufacturer should not continue placing MDR devices on the market without the required authorised representative. Importers must in particular verify that an authorised representative compliant with Article 11 has indeed been appointed.
Continuity of the mandate must therefore be secured, while taking account of the exact scope of the devices covered, their regulatory status and the distribution chain.
What the MDR provides for a change
Article 12 of the MDR expressly frames the change of authorised representative. It provides that the detailed arrangements be defined in an agreement between the manufacturer, the incoming representative and, where possible, the outgoing representative.
That agreement must at minimum specify:
- the end date of the outgoing mandate and the start date of the new one;
- the date until which the outgoing representative may still appear in the information supplied by the manufacturer, including promotional material;
- the conditions for transferring documents, particularly as regards confidentiality and ownership;
- the outgoing representative’s obligation to forward, after the end of its mandate, the complaints and incident reports received concerning the devices covered by that mandate.
The regulation sets no general notice period of 30, 60 or 90 days. Such periods may be provided for in providers’ contracts, but they are not a uniform rule derived from the MDR. The timetable must be built from the existing contract, the operational capacity of the incoming representative and the time needed to update the regulatory information.
Organising the transition in six steps
1. Analyse the existing mandate. Before any notice of termination, the manufacturer must examine the clauses on duration, notice, early termination, return of documents and cooperation after the end of the contract.
It is also worth verifying the scope of the mandate: devices covered, codes or generic groups, markets concerned, vigilance obligations and any additional services. A blanket termination should not be assumed where several regulatory scopes or device families are involved.
2. Select and qualify the new authorised representative. The manufacturer must assess the new EC REP’s ability to carry out the tasks set out in Article 11: documentary verification, retention of documents, cooperation with the authorities, handling of requests and forwarding of vigilance information.
Signing the new mandate before serving notice of termination is generally good risk-management practice. It is not, however, sufficient on its own: the effective date, the devices covered and any conditions precedent must be precisely defined.
3. Formalise a transition agreement. The agreement provided for by Article 12 must avoid any gap between the two mandates. In practice, the end date of the outgoing mandate and the start date of the incoming one must be coordinated unambiguously.
That agreement must also organise the transfer of documents, the forwarding of complaints received after the end of the mandate, and the period during which the former EC REP may still be mentioned in the information supplied with the device.
This last point is essential. The MDR does not necessarily require every mention of the outgoing representative to be replaced instantly on the day the new mandate takes effect. A transition period may be agreed. Its length must be justified, documented and consistent with stock control and traceability.
4. Update the documentation and labelling. The name and address of the authorised representative normally appear on the labelling of devices manufactured outside the EU. They also appear in the EU declaration of conformity. The relevant label templates, instructions for use, packaging and commercial documents must therefore be inventoried.
The manufacturer should draw up an action plan identifying:
- the documents to be amended;
- the batches and stock concerned;
- the date from which the new packaging is used;
- the rules applicable to stock already manufactured;
- the evidence needed to demonstrate the consistency of the transition.
The cut-off date for using the former representative’s details must follow from the transition agreement provided for in Article 12. The vague formula “within a reasonable time” should be avoided if it is not backed by documented criteria.
5. Update EUDAMED and inform the parties concerned. The change is not a simple “transfer of EUDAMED access”. The manufacturer and the authorised representatives take part in managing their mandate relationship in the Economic Operators module. The link with the new representative, the mandate summary and the relevant data must be updated in line with the applicable workflow.
Since 28 May 2026, the Economic Operators module has been among the EUDAMED modules whose use is mandatory. The Commission states that a non-EU manufacturer must have an active authorised representative and provide a mandate summary for its registration. The SRN identifies the economic actor; continuity or any adaptations must be verified in the relevant file, without systematically presenting a change of EC REP as the creation of a new SRN. See the official documentation for the EUDAMED Actor registration module.
Where the authorised representative appears on certificates issued by a notified body, that body must be included in the transition timetable. This step should not be neglected. The manufacturer is strongly advised to review the contract with its notified body to identify when the change must be reported to it, so as to avoid any slowdown or blockage in the project. The EUDAMED documentation provides in particular for the possibility of an amended version of a certificate where the authorised representative changes.
Importers and distributors must also receive the information they need to perform their own checks and to avoid inconsistencies in the supply chain.
6. Secure the post-mandate period. The outgoing representative may still receive complaints or reports after the end of its assignment. The agreement must define a transmission channel, contact points, deadlines and a period of application.
It is also prudent to document the return or destruction of copies, the mandatory regulatory retention, the handling of personal data, confidentiality and access to archives in the event of a request from an authority.
What timelines should you plan for?
No single regulatory deadline can be announced for changing EC REP. The timetable depends in particular on:
- the contractual notice period;
- the assessment carried out by the incoming representative;
- the number of devices concerned;
- the lead times for amending labels and instructions for use;
- stock management;
- the operations to be performed in EUDAMED;
- the possible involvement of a notified body;
- any residual national obligations that apply;
- the timelines notified bodies impose for processing this type of change.
In practice, the backward plan must start from the intended end date of the mandate and build in sufficient margin. A contractual notice period of 30 to 90 days may exist, but it should not be presented as a general rule.
Main risks for the manufacturer
The most significant risks are the absence of a valid authorised representative, overlapping and contradictory mandates, incomplete coverage of the devices, inconsistent labels, an obsolete EU declaration of conformity or out-of-date EUDAMED data.
To these are added the risks of a break in complaint handling, loss of access to certain documents, failure to inform the notified body, and products being blocked by an importer or an authority.
Particular attention is needed where the mandate is broken because of a failure by the manufacturer. Article 11 provides that a representative terminating on that ground must immediately inform its competent authority and, where applicable, the notified body, stating the reasons for the termination.
Contractual clauses to anticipate
The mandate contract should frame from the outset the notice period, the cooperation arrangements, exit fees, the return of documents, confidentiality, rights of access to files, the handling of late complaints and the updating of regulatory information.
It should also define the consequences of a termination motivated by non-compliance on the manufacturer’s side. In that situation, commercial continuity cannot be pursued at the expense of correcting the regulatory problem that caused the break.
Key takeaways
Changing EU authorised representative is a cross-cutting regulatory project. The priority is not merely to sign a new contract, but to align the mandate dates, the scope of devices, the documentation, the labelling, EUDAMED, the certificates and the handling of complaints.
The transition must be set out in writing in accordance with Article 12 of the MDR. The applicable notice period is primarily contractual, while the period for using the outgoing representative’s details must be explicitly agreed and controlled.