What does “sole” mean in MDR Article 11(1)?

It means exclusive per generic device group rather than exclusive per company. Article 11(1) requires designation of a sole authorised representative, and Article 11(2) makes each mandate effective at least for all devices of the same generic device group. The exclusivity therefore attaches to the group: one group, one representative, at any given time.

Can two authorised representatives cover the same device in different EU countries?

No. A mandate operates for the whole Union, not for a territory, and Article 11(2) sets its minimum scope as all devices of the same generic device group. Dividing one group between representatives by Member State would place two representatives on that group, which MDCG 2022-16 says should not happen. Territorial arrangements belong to distribution contracts, not to the mandate.

Is it a problem if two authorised representatives show in EUDAMED at the same time?

Not by itself, during a governed change-over. Article 12 requires an agreement fixing the termination date of the outgoing mandate and the start date of the incoming one, so only one mandate is legally live on any given day. A brief overlap in registration data, and a longer run-off on labels under Article 12(b), are expected. An overlap with no dated agreement behind it is the problem.

How should a mandate define its scope to avoid a gap?

Name the generic device groups in Article 2(7) terms first, then list Basic UDI-DIs or model families as illustration only, and add a clause extending the mandate to every device of those groups placed on the market during its term, including variants and successors. A model-number-only annex goes stale each time a new variant launches and leaves the labelling and EUDAMED records contradicting the written mandate.

Which MDCG guidance covers the sole authorised representative rule?

MDCG 2022-16, Guidance on Authorised Representatives Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), endorsed in October 2022. Section 4 deals with designation and mandate, section 8 with termination and section 9 with change of representative. MDCG documents are not legally binding but authorities work from them.

Sole Authorised Representative: What MDR Article 11(1) Actually Restricts

Q: Can a manufacturer have more than one EU authorised representative?

Yes, if the devices fall into different generic device groups. MDCG 2022-16 states that a manufacturer can have more than one authorised representative where the devices fall under different generic device groups, but that only one should be designated for any single group. So a portfolio split by product family is permissible, while two representatives sharing one group is not.

Q: What is a generic device group under MDR Article 2(7)?

Article 2(7) defines it as a set of devices having the same or similar intended purposes or a commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics. It is a judgement based on intended purpose or technology, not a code. It is not the same thing as a Basic UDI-DI, an EMDN code or a notified body device family.

Sep 6

7 min read

Article 11(1) of Regulation (EU) 2017/745 requires a non-EU manufacturer to designate a "sole authorised representative", but "sole" does not mean one company for the whole catalogue. It means one authorised representative per generic device group, because Article 11(2) fixes the mandate as "effective at least for all devices of the same generic device group". A manufacturer with several unrelated product families may therefore lawfully appoint different EU representatives for different families; what it may not do is put two of them on the same group.

What Article 11(1) actually says — and what it does not

The operative sentence is short. MDR Article 11(1) provides: "Where the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if the manufacturer designates a sole authorised representative." Read alone, that wording invites the assumption that a manufacturer gets exactly one representative, full stop. Read together with the very next paragraph, it does not.

Article 11(2) states: "The designation shall constitute the authorised representative's mandate, it shall be valid only when accepted in writing by the authorised representative and shall be effective at least for all devices of the same generic device group." Two things follow. First, the mandate has a statutory minimum scope — you cannot carve a single generic device group into slices. Second, the unit to which the exclusivity in "sole" attaches is the generic device group, not the manufacturer as a legal person. The duties that sit inside that mandate are set out in Article 11(3) and are covered in our guide to MDR Article 11; this article is only about scope.

The generic device group is the unit the rule bites on

Article 2(7) MDR defines the term as "a set of devices having the same or similar intended purposes or a commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics". It is deliberately broad and deliberately not a code. A generic device group is not a Basic UDI-DI, although a well-constructed Basic UDI-DI often sits inside one; it is not an EMDN code, although EMDN nomenclature is a reasonable starting point for arguing the boundary; and it is not a notified body "device family" from a certificate schedule.

Because the definition turns on intended purpose or common technology, the boundary is a judgement the manufacturer has to make and be able to defend. Non-invasive wound dressings and implantable orthopaedic screws plainly sit in different groups. A powered infusion pump and its dedicated administration set are far harder to separate. The safe rule of thumb: if you would struggle to explain to a competent authority why two devices are in different groups, treat them as one group and give them one representative.

Can a manufacturer use more than one sole authorised representative?

Yes, subject to the group rule, and this is stated expressly in endorsed guidance. MDCG 2022-16, Guidance on Authorised Representatives Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) (October 2022), says at section 4: "As regards its portfolio of devices therefore, a manufacturer can have more than one authorised representative if the devices fall under different generic device groups". The same paragraph then closes the door on the other reading: "However, for one specific generic device group, the manufacturer should designate only one authorised representative".

MDCG documents are endorsed by the Medical Device Coordination Group and are not legally binding, but competent authorities and notified bodies work from them, so a portfolio split that contradicts MDCG 2022-16 will be questioned. Note also that MDR and IVDR are separate Regulations with separate device populations: appointing one representative for your medical devices and another for your in vitro diagnostics raises no Article 11(1) problem at all.

Which splits are compatible with the sole authorised representative rule

Arrangement	Compatible with Article 11(1)?	Why
One representative for the entire portfolio	Yes	Always compliant, and the simplest to evidence in EUDAMED, on labels and on the Declaration of Conformity.
Representative A for wound care, Representative B for surgical instruments	Yes	Different intended purposes and technologies, so different generic device groups under Article 2(7).
Two representatives both mandated for the same generic device group	No	Directly contrary to MDCG 2022-16: only one representative per group.
Representative A for Germany and France, Representative B elsewhere, same devices	No	A mandate is Union-wide. Territorial slicing gives one group two representatives.
Representative A for MDR devices, Representative B for IVDR devices	Yes	Separate Regulations and separate device populations; no overlap of groups.
Representative A for Class I self-certified devices, Representative B for the certified range in the same group	No	Risk class is not the dividing line; the generic device group is.
Time-boxed overlap during a documented change of representative	Yes	Article 12 fixes the termination and start dates, so only one mandate is live on any given day.

Writing the mandate scope so there is no gap and no overlap

Most scope failures are drafting failures. Two patterns cause almost all of them.

The gap pattern: the mandate annex lists individual model numbers and nothing else. The manufacturer launches a new model inside an existing group, forgets to amend the annex, and the label, the Declaration of Conformity and the EUDAMED device record then point at a representative whose written mandate arguably does not cover that model. Article 11(2) sets a statutory floor of the whole generic device group, so the device is not left unrepresented in law — but the paperwork now contradicts itself, which is exactly what an inspection finds.

The overlap pattern: two mandates with two different representatives are drafted from marketing catalogues rather than from intended purposes, and their descriptions collide on a borderline product. Each representative believes the other holds it; complaints and field safety notices are routed to whichever address the label happens to carry.

Draft the scope in this order. Name the generic device groups first, in Article 2(7) language, and list Basic UDI-DIs or model families underneath as illustration only. Add a clause stating that the mandate extends to every device of a named group placed on the Union market during its term, including variants and successors, so annex drift cannot create a gap. Where a second representative exists, cross-reference the groups it holds and state that neither mandate extends to the other's groups. Finally, record who holds any borderline device by name. Termination discipline follows from the same logic: MDCG 2022-16 notes that "the termination of the mandate is only possible with respect to the whole generic device group and not a specific device within that group, unless the specific device is removed/withdrawn from the market and so is outside the scope of the effective mandate".

The change-over window, when two representatives appear in EUDAMED

During a hand-over it is normal for an outgoing and an incoming representative to be visible against the same manufacturer for a short period. That is a data state, not a second designation, provided the dates are governed. Article 12 MDR requires that "The detailed 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." The agreement must address, among other things, "the date of termination of the mandate of the outgoing authorised representative and date of beginning of the mandate of the incoming authorised representative" and "the date until which the outgoing authorised representative may be indicated in the information supplied by the manufacturer, including any promotional material".

Those two dates do different jobs. The first must leave no unrepresented day: if the old mandate ends on the 30th and the new one starts on the 1st of the following month, devices placed on the market in between have no representative. The second deliberately permits the outgoing name to remain on labels and existing stock for a defined run-off, which is why EUDAMED, packaging and promotional material can legitimately disagree for a while. MDCG 2022-16 adds that a tripartite agreement should normally exist, except where involving the outgoing party is not practicable — insolvency, dissolution or loss of contact. The registration and hand-over mechanics themselves are covered in our post on the change of authorised representative and on EUDAMED SRN registration.

What this costs a manufacturer with several product families

Splitting a portfolio between two or more sole authorised representatives is lawful, but it is not free. Each representative registers separately in EUDAMED and holds its own SRN, so your actor data is fragmented. Each must keep a copy of the technical documentation and the Declaration of Conformity for its own groups, which means two document transfer channels and two sets of update obligations. Labels and instructions for use must carry the correct representative for that device's group — a single wrong EC REP block on a shared carton is a labelling non-conformity. Vigilance and competent authority correspondence split along the same line, and a borderline device produces exactly the routing failure the group rule exists to prevent.

There are good reasons to accept that cost — a family acquired with its own representative, a legacy arrangement with an unexpired term, or genuinely unrelated business units. There are poor ones, chiefly price shopping across a portfolio that is really one group. If you are still choosing, our post on choosing an EU authorised representative sets out the selection criteria, and published class-based annual fees are on our pricing page.

Where Medex fits

Medex acts as an EU authorised representative under MDR and IVDR, registered in EUDAMED with SRN TR-AR-000057550, with an in-house Person Responsible for Regulatory Compliance and a deputy, and offices in Ankara, İstanbul and Gdańsk. We draft mandate scopes by generic device group so a split portfolio leaves no gap, but we do not perform notified body conformity assessment, do not write clients' technical documentation and do not find distributors — talk to us if you need the representation itself.