Many manufacturers outside the EU, including many UK manufacturers after Brexit and Swiss manufacturers after 2021, appointed an EU Authorised Representative (AR) under time pressure. Some of those relationships work well. Others turned out to be an address that forwards post and struggles to answer a competent authority’s question.
Changing AR is possible at any time. It is regulated, though, and the change has to be managed so there is never a gap in representation.
What Article 12 of the MDR requires
The detailed arrangements for a change of AR must be clearly defined in an agreement between the manufacturer, the outgoing AR and, where practicable, the incoming AR. That agreement must address at least:
- Dates: the date the outgoing AR’s mandate ends and the date the incoming AR’s mandate begins.
- Transition of information: the date until which the outgoing AR may still be indicated in the information you supply, including promotional material.
- Documents: the transfer of documents, including confidentiality aspects and property rights.
- Vigilance: the outgoing AR’s obligation, after its mandate ends, to forward to you or the incoming AR any complaints or reports of suspected incidents it receives about devices it represented.
The practical steps around the agreement
The agreement is the legal core, but a clean switch involves more than signing it.
- Check your current mandate. Look for the notice period, termination terms and any fees for document transfer.
- Agree the dates first. Choose a handover date that leaves time for labelling and documentation updates, and make sure the new mandate starts the day the old one ends.
- Update your declaration of conformity. The EU declaration of conformity identifies your Authorised Representative (MDR Annex IV), so it needs to be reissued with the new AR’s details.
- Plan labelling changes. Your AR’s name and address appear on the label. Agree realistic dates for new labels and IFUs, and use the Article 12 agreement to cover stock already labelled with the outgoing AR.
- Update EUDAMED. Make sure your actor record reflects the new AR mandate, and that the new AR can meet its obligation to verify your registrations.
- Transfer the technical documentation. The incoming AR must be able to make your technical documentation available to authorities from day one.
- Check with your notified body whether it needs to be informed of the change for your certificates and files.
- Tell your importers and distributors. They verify your AR designation too, and they’ll need the updated documents.
When is the right time?
The simplest moment is a planned trigger you already have: a mandate renewal, a new product launch, a labelling revision or a recertification. It also makes sense to review your AR arrangement now that EUDAMED registration is mandatory, because your AR has to verify your registrations and many manufacturers are updating their EUDAMED data before 28 November 2026.
Questions to ask a new AR
- Who is your PRRC, and how can we reach them?
- What response times do you commit to for competent-authority requests?
- How will you verify our technical documentation and registrations before accepting the mandate?
- Do you also act as importer or provide consultancy? If so, how do you keep those roles separate?
- What exactly is included in the annual fee?
Where MD QMS SRL fits
Our EU Authorised Representative service is in development and not yet open for mandates. When it opens, we will manage the switching process with you and your current AR. If you would like to be told as soon as it does, join the launch list. In the meantime, MD QMS SRL can already act as your EU importer.
This article summarises Article 12 of Regulation (EU) 2017/745 as of September 2026 and is not legal advice. Always refer to the current consolidated text.