Change of Authorised Representative: How to Do It Without Losing Market Access
Updated: Aug 30
Manufacturers change authorised representative for ordinary reasons: price, service quality, a provider that stopped answering, a merger that made the relationship awkward. The regulation provides for a change of authorised representative, but it is not a simple substitution and it does not happen by sending an email.
What Article 12 requires for a change of authorised representative
Article 12 of Regulation (EU) 2017/745 governs the situation. Where a manufacturer replaces its authorised representative, the modalities of the change are defined clearly in an agreement between the manufacturer, the outgoing representative and the incoming representative.
That agreement addresses the date on which the outgoing mandate terminates and the date on which the incoming mandate begins. It also addresses the transfer of documents, including confidentiality and property rights.
The outgoing representative does not simply disappear from the picture. Its obligations continue in respect of devices placed on the market during the period of its mandate, and the documentation it holds has to reach the incoming representative rather than being archived or destroyed.
The three things that go wrong
A gap between the mandates
If the outgoing mandate ends on the last day of a month and the incoming one begins on the first day of the next, there is a period during which the device has no authorised representative. Devices should not be placed on the market during any such interval.
The dates should meet exactly or overlap. This is the single easiest thing to get right and the single most common thing to get wrong, because the two contracts are usually negotiated separately.
Documentation that does not move
A representative in dispute with a manufacturer holds the technical documentation and the correspondence history. Recovering it can be slow, and a slow recovery delays the incoming representative's ability to perform its verification duties under Article 11(3)(a).
This is precisely why the transfer belongs in the Article 12 agreement rather than in a subsequent request. Agreed in advance it is administration; requested afterwards it is leverage.
Labels that still name the outgoing party
The label identifies the authorised representative by name and registered address. Devices already in the supply chain carry the previous name, and the practical question is what happens to that stock.
Artwork revision, printing and depletion of existing stock is usually the longest item on a transition timeline — longer than the regulatory steps. Plan it first rather than last.
What to check before you start a change of authorised representative
Read your current mandate. Notice periods, exit conditions and any termination charge are in that document, and they will determine your timeline more than the regulation does. A twelve-month notice period is not unusual and it is not negotiable after the fact.
Establish what your outgoing representative holds. Technical documentation, declarations, certificates, correspondence with authorities, EUDAMED access — list it before you announce the change rather than after.
Ask the incoming representative how many transitions it has completed and what it does when the outgoing party is uncooperative. The answer distinguishes a provider that has done this from one that has read about it.
After the change of authorised representative
EUDAMED records need updating: the mandate link between manufacturer and representative is registered in the database and must reflect the new arrangement. Where you also hold registrations in national systems — Türkiye's ÜTS among them — those records identify the representative too and must be updated in parallel.
A change completed in EUDAMED but not in national systems leaves an inconsistency that is visible to anyone who checks both, and inconsistency between databases is itself a finding.
Sources
Regulation (EU) 2017/745, Article 12 — change of authorised representative
Regulation (EU) 2017/745, Article 11(3) and Article 11(5)
Regulation (EU) 2017/746, Article 12
MDCG 2022-16 — guidance on authorised representatives
Who wrote this
Medex is a medical device manufacturer established in Ankara and a registered authorised representative in EUDAMED under SRN TR-AR-000057550. We are not a law firm and do not provide legal advice. Send us your device list and we will respond in writing.
Medex takes on incoming mandates as EU authorised representative, and where the manufacturer also sells into Türkiye we hold the ÜTS registrations so the two records do not drift apart during a transfer.
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