Changing Your Authorised Representative Under MDR Article 12

1. Key takeaways

Under Article 12 of the MDR, a change of authorised representative requires an appropriate agreement laying down the arrangements between the manufacturer, the outgoing authorised representative and the incoming authorised representative. That agreement must cover at least the termination date of the old mandate and the effective date of the new mandate, the handover of copies of documents, and the responsibility for updating the registration information in EUDAMED, including the Single Registration Number (SRN). The change is legally structured as a three-party transaction, not as two separate bilateral terminations and signatures. The central risk during a change is a gap in the custody of document copies: Article 11(3)(b) requires the authorised representative to keep copies of the technical documentation, the declaration of conformity and certificates available for competent authorities, and if no party holds the copies during a transition window, the manufacturer has no answer when an authority requests them. Planning the change with overlap periods, a signed handover list and a defined EUDAMED update owner converts a regulatory risk into a managed project.

2. Legal basis

The change procedure and the obligations that continue to apply during a change are set out in the following provisions.

3. Expert insights

Insight one: the legal form of a change is a three-party agreement, not two bilateral deals.

Article 12 expressly requires an agreement covering the arrangements between the manufacturer, the outgoing authorised representative and the incoming authorised representative. Signing two separate bilateral documents cannot cover the handover responsibilities, and in particular the specific question of who holds the copies of the technical documentation during the transition period. Only a three-party instrument can allocate custody, define the overlap, and assign the EUDAMED update duty to a named party with a deadline. Manufacturers sometimes resist the extra coordination, but the three-party form is precisely what protects them: if a competent authority requests documents during the change window, the agreement identifies who must respond and by when.

Insight two: the handover of document copies is the core risk point of the transition.

Article 11(3)(b) requires the authorised representative to keep copies of the technical documentation, the EU declaration of conformity and certificates, including any amendments and supplements, available for inspection by competent authorities. If a copy gap arises during the change, there is no party able to respond when the authority requests access, and the responsibility falls on the manufacturer. The handover list should therefore cover the technical documentation copies, declarations of conformity, certificates with their amendments and supplements, registration data exports, and the complaint and vigilance history. Signing the handover list on both sides — and dating the moment custody passes — is the simplest possible evidence that no gap existed.

Insight three: registration information must be updated in step.

The authorised representative must complete its own registration under Article 31 and obtain a Single Registration Number (SRN). After the change, the economic operator records and the device records in EUDAMED that are linked to the authorised representative must be updated in sync. The relevant EUDAMED modules become mandatory from 2026-05-28 (Commission Decision (EU) 2025/2371), and records that are not updated directly impair traceability. In an inspection, a device record that still names the former representative creates an inconsistency that is easy for an authority to find and hard to explain away, so the EUDAMED update should be treated as a gating step rather than housekeeping.

Insight four: the termination notification duty still applies in a change scenario.

Where the change is caused by a breach of the manufacturer’s obligations, the outgoing authorised representative must still terminate the mandate under Article 11(3)(h) and inform the competent authority of the Member State in which it is established and, where applicable, the notified body. A change agreement cannot waive this statutory duty. The parties should therefore distinguish in the agreement between a neutral change at the manufacturer’s initiative and a termination for breach, because the notification consequences differ and the authority may have questions either way.

4. Practical recommendations

1. Draft the three-party agreement as soon as the change project starts, fixing the termination date, the effective date and an overlap period (an overlap is advisable, with no custody gap).
2. Include in the handover list: copies of the technical documentation, declarations of conformity, certificates with amendments and supplements, registration data exports, and complaint and vigilance history records.
3. Define the responsible party and the completion deadline for updating the EUDAMED registration information.
4. Reconfirm the PRRC arrangement with the new authorised representative (Article 15(6)).
5. After the change is completed, inform the relevant distributors and importers of the new authorised representative’s contact details and labelling information.

5. Verification checklist

Confirm each of the following before closing out the change project.

• □ The three-party agreement has been signed (manufacturer, outgoing, incoming)
• □ The termination date and effective date are defined, with no liability gap
• □ The handover list of technical documentation and certificate copies has been signed
• □ The responsible party and deadline for the EUDAMED update are agreed
• □ The new authorised representative has confirmed the PRRC arrangement (Article 15(6))
• □ The information notice to importers and distributors has been completed

Regulatory information verified as of 29 October 2026.

GRZAN supports manufacturers and incoming authorised representatives through the full change cycle under Article 12 of the EU MDR: drafting three-party agreements, managing handover lists for technical documentation and certificates, updating EUDAMED registration records and Single Registration Number linkage, and reconfirming PRRC arrangements. We also provide fee and budget planning for notified body conformity assessment so that a change of representative does not destabilise your compliance spending. Manufacturers without an establishment in the European Union can rely on our team for Article 11 mandate services and inspection readiness under Regulation (EU) 2017/745. For practical support, contact GRZAN at info@grzanglobal.com.