How to Change Your EU Authorized Representative: The Complete 2026 Transfer Guide

To change your EU Authorized Representative, you sign an Article 12 agreement between yourself, the outgoing representative where practicable, and the incoming one, fixing termination and commencement dates, document transfer and complaint forwarding. You then update your EUDAMED actor data and your labelling. Article 12 sets no notice period of its own; your existing contract usually does.

In brief

• Article 12 requires a written agreement between you, the incoming AR and, where practicable, the outgoing AR.
• That agreement must fix dates, document transfer and post-mandate forwarding of complaints.
• An SRN belongs to an economic operator, not to a manufacturer-AR relationship.
• Devices already lawfully placed on the market need not be withdrawn or relabelled.
• EC REP and EU REP symbols coexist from 17 June 2026 to 17 June 2031.

“EU Authorized Representative”, “EU authorised representative”, “EC REP” and “EU REP” are one legal role: the person or company established in the Union that a non-EU manufacturer designates under Article 11 of Regulation (EU) 2017/745. Spelling varies by market; the obligations do not. This page covers how to change EU Authorized Representative arrangements without breaking your route to market.

Why manufacturers change their EU REP

Manufacturers asking how to change EU Authorized Representative providers are usually solving one of five problems, and only one is price.

• Service failure. Authority requests sit unanswered, or nobody can say where your technical documentation copy is held.
• Cost structure. Per-registration and per-UDI charges turn a small line item into a large one; the EU authorised representative cost breakdown explains class-based pricing.
• Scope. You add a device family outside the generic device group your mandate covers, so the designation reopens anyway (MDR Art. 11(2)).
• The representative pulls out. An AR must terminate the mandate where the manufacturer acts contrary to its obligations (MDR Art. 11(3)); MDCG 2022-16 confirms this affects the entire generic device group.
• Jurisdiction. Where the Regulation refers to the competent authority of the manufacturer's Member State, it means the State where your AR is established (MDR Art. 11(7)). Switching changes who supervises you.

Before you switch EU REP, be clear which problem you are solving; a cheaper mandate that repeats the same failure costs more than it saves. The EU authorised representative companies comparison sets out what to test, and the difference between an AR, an importer and a PRRC is worth checking first.

What MDR Article 12 actually requires

Article 12 does not prescribe a process. It prescribes an agreement. The arrangements for a change of authorised representative “shall be clearly defined in an agreement between the manufacturer, where practicable the outgoing authorised representative, and the incoming authorised representative” (MDR Art. 12). It must cover four things:

1. the date the outgoing mandate terminates and the date the incoming mandate commences;
2. how long the outgoing representative may still appear in your information, including promotional material;
3. the transfer of documents, including confidentiality and property rights;
4. the outgoing representative's obligation, after the mandate ends, to forward to you or the incoming representative any complaints or reports of suspected incidents.

Three rules sit around Article 12 rather than inside it. You may designate only one authorised representative at a time (MDR Art. 11(1)). The designation is valid only once the incoming representative accepts it in writing, and must cover at least the whole generic device group (MDR Art. 11(2)). The mandate cannot move the manufacturer obligations listed in Article 11(4), those under Article 10(1) to (4), (6), (7) and (9) to (12), onto anyone else; the guide to MDR Article 11 authorised representative obligations sets the role out in full. The simplification package COM(2025) 1023, adopted 16 December 2025 and still not law on 20 August 2026, does not propose amending Articles 11, 12, 30 or 31.

How to change EU Authorized Representative cover without a gap

The rule is continuity: to transfer authorised representative duties safely, the incoming mandate must not commence after the outgoing one terminates. A gap leaves a device on the Union market with no designated representative, the state Article 11(1) exists to prevent.

The tripartite agreement and what must be in it

MDCG 2022-16 calls this a tripartite agreement: manufacturer, outgoing AR, incoming AR. Treat the four statutory items as a minimum and negotiate the detail, which is where transfers stall.

Article 12 requirement	What to write in	Why it matters
Termination and commencement dates	Two calendar dates, the incoming mandate starting on or before the outgoing one ends	Prevents any gap in designation (MDR Art. 11(1))
Continued appearance of the outgoing AR	An end date for label artwork, IFU, catalogues, website and promotional material	Required by Article 12; it sets your relabelling workload
Transfer of documents	Technical documentation copy, EU declaration of conformity, certificates, complaint and authority correspondence, confidentiality and property rights	The AR keeps this available to authorities for 10 years, 15 for implantables (MDR Art. 11(3); MDCG 2022-16)
Post-mandate forwarding	A named contact, a route and a duration for reports arriving after termination	Vigilance signals that reach a former representative and stop there

Add the clauses Article 12 does not name: who holds master artwork files, who answers an authority request arriving on the handover date, and what happens to registration data filed on your behalf. The mandate agreement guide covers the incoming mandate itself.

What happens if your outgoing AR is untraceable or has ceased trading

The tripartite requirement is waived. MDCG 2022-16 states it is not required where the outgoing representative is untraceable or has ceased operations, matching the “where practicable” wording in Article 12. That does not make the transfer free of work; it makes it a documentation exercise:

1. Record your contact attempts: dates, addresses, named people, responses or silence. That is your evidence the waiver applies.
2. Rebuild the document set from your own files. Your Article 10 obligations were never delegable (MDR Art. 11(4)), so the technical documentation, DoC and certificates are yours to supply.
3. Reconstruct the complaint and vigilance trail as far as you can, and note where it is incomplete.
4. Ask the competent authority in the outgoing representative's Member State how it wants the situation handled before assuming anything about existing registrations.

EUDAMED: who owns the actor record and the SRN

Start from the right premise. A Single Registration Number is not a property of the relationship between you and your representative. Under Article 31 the competent authority verifies the submitted data, obtains an SRN from the electronic system and issues it to the economic operator; the SRN identifies that operator.

Manufacturers, authorised representatives and importers each register and each hold their own number (MDR Art. 31). Your manufacturer SRN is what you use when applying to a notified body and when accessing EUDAMED. The outgoing representative's SRN belongs to that company; the incoming one arrives with its own. No number moves between the parties.

The actor registration flow is short (MDR Art. 31; Commission Decision (EU) 2025/2371):

1. The economic operator submits a registration request.
2. The national competent authority assesses and approves it.
3. EUDAMED generates the Actor ID / SRN.

Two facts bear on a transfer. A non-EU manufacturer registering in EUDAMED must have an active authorised representative and submit a mandate summary document, so the incoming mandate has to exist first. And registration data must be updated within one week of any change, with accuracy confirmed within one year of submission and every second year after (MDR Art. 31).

Where the published sources stop. The mechanics of replacing the representative recorded against an existing EUDAMED actor record are not settled in the guidance relied on here: who initiates it, what the outgoing representative must confirm, how it is validated. We will not invent a screen flow. Ask the authority that will supervise you after the change, in writing, before fixing a handover date; the EUDAMED actor registration and SRN guide flags the same gap. The four first EUDAMED modules, actor registration included, have been mandatory since 28 May 2026 (Commission Decision (EU) 2025/2371).

Notified body and competent authority notification sequence

The notification duty on termination sits with the representative, not with you. An AR that terminates the mandate must immediately inform the competent authority of its Member State and, where applicable, the notified body, giving the reasons (MDR Art. 11(6)). Require written confirmation. A workable order of operations:

1. Sign the incoming mandate and obtain written acceptance (MDR Art. 11(2)).
2. Sign the Article 12 transfer agreement with both representatives, with dates that leave no gap.
3. Confirm the outgoing representative has notified its authority and, where applicable, your notified body under Article 11(6).
4. Notify your notified body in writing and ask what it needs on file; your SRN is used when applying to a notified body (MDR Art. 31).
5. Update registration data within one week of the change taking effect (MDR Art. 31), by the procedure the authority confirms.
6. Tell importers and distributors, who must verify that an AR has been designated in accordance with Article 11 (MDR Art. 13(2)(b)).

Labels, IFU and packaging: the transition plan

Your label carries the representative's identity next to the EC REP or EU REP symbol, so changing representative is a labelling change. Timing is governed by the date agreed under Article 12 for how long the outgoing representative may still appear in your information.

Work through artwork in order: primary label, outer packaging, instructions for use, implant card where applicable, declaration of conformity, catalogues, website. Set a cut-over date for new production and a separate position for existing stock. Relabelling or repackaging by a distributor or importer is different: under Article 16 that operator must indicate the activity and its details, operate a QMS, notify you and the competent authority at least 28 days in advance, and hold a notified body certificate covering that QMS (MDR Art. 16(3), 16(4); MDCG 2021-26). COM(2025) 1023 proposes removing the certificate and the notice period, but it is a proposal, not law.

Translation and a change of outer packaging, including pack size, are not modifications where the device's original condition is unaffected (MDR Art. 16(2)). See the EU REP labelling requirements guide.

Devices already placed on the market: do you need to relabel?

No. Two separate rules point the same way.

First, the sell-off deadline was deleted. Devices lawfully placed on the market before the transition ends may continue to be made available or put into service with no time limit, subject only to shelf life (Reg. (EU) 2023/607; Commission Q&A Rev.2, July 2024). The same applies under IVDR Article 110(4).

Second, on the symbol: devices already on the market bearing “EC REP” may remain in circulation, and existing labelling stays valid (MDCG 2021-5 Rev.1 Appendix, June 2026; Commission Implementing Decision (EU) 2026/1231).

What the sources do not resolve is finished, labelled stock you still hold at handover and have not yet placed on the market. That turns on when each unit is placed on the market, not on Article 12, and the guidance relied on here does not address it. Document your reasoning and confirm it with your competent authority if the volume is material.

Using the EU REP symbol coexistence window to your advantage

If you have to change EC REP details on artwork anyway, do the symbol update in the same revision. EN ISO 15223-1:2021/A1:2025 replaces “EC REP” with “EU REP”, and Commission Implementing Decision (EU) 2026/1231 of 11 June 2026, OJ 17 June 2026, lists it as harmonised at Annex item 12a.

The window runs 17 June 2026 to 17 June 2031, sixty months. During it you may use one symbol or both, on different packaging levels, and staggered implementation is expressly permitted. After 17 June 2031 only “EU REP” gives a presumption of conformity.

The useful part for a transfer: the change is “purely editorial in nature”, needs no prior notified body approval for relabelling, and does not change the representative's role, responsibilities or establishment requirements (MDCG 2021-5 Rev.1 Appendix, June 2026). Sequencing across packaging levels is covered in the EC REP to EU REP symbol change guide.

Contract red flags: notice periods, auto-renewal, document hostage clauses

The law rarely blocks a transfer. Contracts do. Read the outgoing agreement first, then the incoming one with the same suspicion.

Clause	What it looks like	What to ask for
Notice period	Long notice measured from a renewal date, not from the notice	Notice running from the date given, plus parallel running for handover
Auto-renewal	Silent annual renewal with a short window to object	A renewal reminder, or renewal only on written confirmation
Document hostage clause	Files released only on settlement of disputed invoices	Unconditional return of your documentation on termination
Exit or handover fees	An unquantified “administrative fee” on transfer	A stated figure. Ours is published: the Article 12 handover fee is €150
Registration charges	Per-registration or per-UDI-DI charges that grow with your catalogue	A stated inclusion. Our scope treats one device as one Basic UDI-DI, unlimited variants under it covered by the base fee, first ten UDI-DI entries included

Our annual fees are class-based and published on the pricing page, the setup fee is €0, and the fee is fixed for three years from signature. One mandate covers the EU and Türkiye. Whoever you choose, read the exit terms before signature.

A realistic 30/60/90 day transfer timeline

This is what a plan to change your EU Authorized Representative usually looks like. Treat it as a planning template, not a promise. Every dependency belongs to someone else: your outgoing representative's notice period, an authority's handling of the EUDAMED actor side, your artwork cycle. No provider, us included, can commit to those dates for you. The only service level we publish is a response to information requests and competent authority requests within one business day.

Window	Focus	Actions
Days 0–30	Decide and paper it	Read the outgoing contract; serve notice on its terms; run due diligence; sign the incoming mandate with written acceptance (MDR Art. 11(2)); draft the Article 12 agreement
Days 31–60	Move documents, notify	Execute the tripartite agreement; transfer the technical documentation copy, DoC, certificates and complaint history; confirm the Article 11(6) notification; ask the authority how the actor change is made
Days 61–90	Registrations, labels, downstream	Update registration data within one week of the change taking effect (MDR Art. 31); release revised artwork; brief importers and distributors (MDR Art. 13(2)(b)); close out post-mandate forwarding

Two rules protect the plan. Do not serve notice until the incoming mandate is signed and accepted, and do not fix a public artwork cut-over date until you know how the competent authority handles the actor change. The AR switching checklist breaks this into assignable items, and our EU authorised representative service examines technical documentation during due diligence, before the mandate is signed.

Sources and further reading

• Regulation (EU) 2017/745 (MDR), consolidated text of 10 January 2025, Articles 11, 12, 13, 16 and 31.
• MDCG 2022-16, Guidance on Authorised Representatives, October 2022.
• MDCG 2021-26 on repackaging and relabelling, October 2021. Note that MDCG 2021-13 Rev.1, July 2021, covers registration of actors other than manufacturers, authorised representatives and importers, so it is not authority for the handover described here.
• Commission Decision (EU) 2025/2371, OJ 27 November 2025; Regulation (EU) 2023/607 and the Commission Q&A on it, Rev.2, July 2024.
• Commission Implementing Decision (EU) 2026/1231, OJ 17 June 2026, with MDCG 2021-5 Rev.1 Appendix, June 2026.
• COM(2025) 1023 final, adopted 16 December 2025: a proposal, not law as of 20 August 2026.

Frequently asked questions

Can I change my EU authorised representative at any time?

Yes, in principle. Article 12 sets no minimum term and no cooling-off period; it requires only that the change be governed by an agreement between you, the incoming representative and, where practicable, the outgoing one. What constrains timing is your existing contract: notice period, renewal date, exit conditions. Keep one representative designated throughout (MDR Art. 11(1)).

Do I need the old AR's cooperation?

Preferably, but not always. Article 12 asks for the outgoing representative to be a party where practicable, and MDCG 2022-16 treats the tripartite agreement as waived where that representative is untraceable or has ceased operations. Cooperation still matters for one thing: complaints and suspected incident reports reaching it after the mandate ends have to be forwarded on.

Do I have to relabel devices already on the EU market?

No. Devices lawfully placed on the market may continue to be made available or put into service with no time limit, subject only to shelf life: the sell-off deadline was deleted (Reg. (EU) 2023/607; Commission Q&A Rev.2, July 2024). Labelling bearing the EC REP symbol stays valid, and devices carrying it may remain in circulation (MDCG 2021-5 Rev.1 Appendix, June 2026).

Who tells the competent authority?

Your outgoing representative does. An AR that terminates its mandate must immediately inform the competent authority of its Member State and, where applicable, the notified body, giving the reasons (MDR Art. 11(6)). Ask for written confirmation. Separately, registration data must be updated within one week of any change (MDR Art. 31), which falls to you and your incoming AR.

How long does an AR transfer take?

It depends on your contract notice period, how fast documents move, and how quickly the competent authority handles the EUDAMED actor side. None of that sits inside one provider's control, so treat any published transfer time as a planning assumption. The 30/60/90 day structure above is a template, not a service level. Our only published service level is a one business day response to information requests.

Can my new AR keep my existing SRN?

The question rests on a misunderstanding. An SRN is issued by a competent authority to an economic operator and identifies that operator (MDR Art. 31). Your manufacturer registration carries its own SRN and your representative its own, so an incoming representative brings its own number. The mechanics of updating the representative recorded against your EUDAMED actor data are not covered by the sources relied on here; confirm them with the competent authority.

Medex is registered in EUDAMED as an authorised representative under SRN TR-AR-000057550, publicly verifiable in the EUDAMED actor database, as any provider's should be. We are not a law firm and do not give legal advice. If you are ready to change your EU Authorized Representative, get a fixed-price EU REP quote (reply within 1 business day): send your device list via the contact page.