Changing Your EC REP Under IVDR Article 12: The Written Handover Agreement

1. Key takeaways

Article 12 is the dedicated provision for changing the authorised representative: except where the manufacturer itself no longer requires an authorised representative, a change must be agreed in a written agreement between the outgoing and the incoming authorised representative and the manufacturer, or, if all three agree, by a joint agreement. The agreement should deal with at least the expiry date of the outgoing party certificates, the cut-off date up to which the original notified body number may be affixed, the handover of documents, the transfer date for subsequent tasks, and, where applicable, the serial number or lot number of the last device manufactured under the old number. Because the sole-representative rule of Article 11(1) continues to apply throughout the transition, the change must be engineered to be seamless: no gap in representation, no overlap of two active mandates, and no break in the chain of documents, registrations and labels that reference the EC REP.

2. Legal basis

3. Expert insights

Insight 1: The core of Article 12 is seamlessness, not a notification.

The failures that most often appear during a change of representative fall into three categories of broken links: documents still held by the outgoing party that were never handed over, entity information in EUDAMED that was never synchronised, and labels in circulation on the market that still carry the name and address of the old authorised representative. Article 12 answers precisely these risks by requiring a written agreement that fixes the handover dates and the dividing line of responsibility. Treating the change as a courtesy notification between two service providers leaves all three failure modes open, and each of them can surface during a market surveillance inspection or an incident investigation, when authorities check whether the representation chain is complete for the devices currently in the supply chain.

Insight 2: The relationship with the notified body needs to be handled in parallel.

Article 11(6) requires that, upon termination of a mandate, the competent authority be notified immediately and, where applicable, the notified body involved in the conformity assessment for the device. A change of representative does not necessarily trigger the termination grounds of Article 11(3)(h), but from a continuity-of-compliance standpoint both the notified body and the competent authority should receive the change information, and the actor data in EUDAMED should be updated in sync (Article 28). Certificates that reference the authorised representative also need attention: under Article 51(5), certificate information is entered into the electronic system of Article 52 and becomes publicly retrievable, so stale representative details in the certificate record are visible to anyone who checks.

Insight 3: The uniqueness principle cannot be broken during the transition either.

Article 11(1) requires the appointment of a sole authorised representative. If the old mandate has not been formally terminated while the new mandate is already in force, two entities simultaneously claim representative status for the same devices, which contradicts the uniqueness rule and confuses authorities and notified bodies alike. The written agreement should fix the termination date of the old mandate and the effective date of the new mandate as the same day, or as directly consecutive dates, so that at every point in time exactly one authorised representative is designated.

Insight 4: Retention responsibility for historical documents does not disappear with the change.

Article 11(3)(b) requires retention of technical documentation and copies of the Declaration of Conformity for the period of Article 10(7), that is at least 10 years from the last device covered by the Declaration of Conformity being placed on the market. After the change, the ownership of this retention responsibility for the historical period must be settled in the agreement. As a rule the manufacturer bears the ultimate responsibility, but the physical custody can be agreed to rest with one of the parties or with a third party, provided the retrieval path for authorities remains defined and testable for the full ten-year window.

4. Practical recommendations

1. State at least four dates in the tripartite written agreement: the expiry date of the old certificates, the cut-off date for affixing the old number, the document handover date and the task transfer date.
2. Attach a handover inventory (technical documentation, Declaration of Conformity, certificate copies, registration data, complaint and vigilance records) and agree the medium and acceptance method of the transfer.
3. Update the EUDAMED actor information (Article 28) and the authorised representative name and address in labels and instructions for use in the same operation.
4. Where the risk of broken links is high for the product concerned, assess whether the Declaration of Conformity and certificate information need to be updated in parallel (Article 51(5)).
5. Issue a written arrangement for long-term retention of historical documents, defining the custodian and the retrieval path for the full 10-year period.

5. Verification checklist

• □ Change agreed in a written agreement signed by the manufacturer, the outgoing party and the incoming party (Article 12)
• □ Agreement states the expiry date of the old certificates and the cut-off date for the old number
• □ Handover inventory, medium and acceptance method agreed
• □ EUDAMED actor information and labels, instructions for use updated in sync (Article 28)
• □ Competent authority and, where applicable, notified body informed of the change (Article 11(6))
• □ Retention arrangement for historical documents for at least 10 years defined (Article 10(7))

Legal information verified as of 2026-10-29.

GRZAN supports in vitro diagnostic manufacturers entering the EU market under Regulation (EU) 2017/746 as EU Authorised Representative (EC REP) and PRRC provider, including Article 12 change-of-representative agreements, document handover planning, EUDAMED registration support and fee budgeting. For transition planning, contact info@grzanglobal.com.