EU Authorized Representative by Device Category: Which Rule Classifies Your Product
Your classification decides how much of the EU conformity route you can complete alone. It does not decide whether you need an authorized representative. Article 11(1) does, and it turns only on where your company is established. For a class I device this appointment is the whole of your EU-side obligation structure: no notified body, no certificate, one mandate.
The appointment does not depend on your class
"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."
Nothing in that sentence mentions risk class, conformity assessment route, or product type. A class III implant and a class I brace are in exactly the same position: if the manufacturer sits outside the Union, one sole authorized representative must be designated before either reaches the market.
What the class does decide is how much else you have to buy. Above class I you also need a notified body, and its certificate is the expensive, slow part. At class I there is no notified body at all — which makes the authorized representative the only EU-side appointment the Regulation forces on you, and the only thing standing between a finished file and a first shipment.
The six categories below are all class I
Each page states the Annex VIII rule that classifies the product, the class it lands in, and whether a notified body enters at all.
| Category | Class | Classification rule | Notified body |
|---|---|---|---|
| Reusable surgical instruments | I (Ir) | Annex VIII, Rule 6, second indent | Limited — reprocessing only |
| Examination and surgical gloves | I / I (Is) | Annex VIII, Rules 1 and 4 | Limited if sterile |
| Orthoses, braces and supports | I | Annex VIII, Rule 1 | None |
| Dental hand instruments | I / I (Ir) / I (Im) | Annex VIII, Rules 5 and 6 | Limited |
| Wheelchairs and mobility aids | I | Annex VIII, Rules 1 and 13 | None |
| Spectacle frames and ophthalmic optics | I | Annex VIII, Rule 1 | None |
Where the limited procedures come from
Three class I situations pull a notified body back in, and Article 52(7) fences it tightly in each:
"(a) in the case of devices placed on the market in sterile condition, to the aspects relating to establishing, securing and maintaining sterile conditions; (b) in the case of devices with a measuring function, to the aspects relating to the conformity of the devices with the metrological requirements; (c) in the case of reusable surgical instruments, to the aspects relating to the reuse of the device, in particular cleaning, disinfection, sterilization, maintenance and functional testing and the related instructions for use."
These are the "Is", "Im" and "Ir" you see written everywhere. None of those suffixes appears in the Regulation itself — they are practitioners' shorthand, used in EUDAMED and in MDCG documents, for a class I device carrying one of the three limited procedures. The certificate that comes out of one covers only the aspect named. It is not an approval of your device.
Your category is not listed
The list above covers the categories where the authorized representative is the only EU-side appointment the Regulation requires. If your device sits above class I, the mandate works exactly the same way — the notified body route runs alongside it, not instead of it. Send your device list and we will tell you which rule applies before quoting.
One appointment, not two: the Union and Türkiye
A frequent question at this point is whether the Union and Türkiye need separate representatives. They do not. Article 11(1) requires a sole authorised representative for the devices concerned, and under the EU–Türkiye Customs Union arrangement that representative may be established in the Union or in Türkiye. One appointment, covering the Union market and Türkiye — not one for each. Our registered place of business is in Türkiye and our EUDAMED authorized representative identifier is TR-AR-000057550; the arrangement is set out in the European Commission's Notice to Stakeholders of March 2022 and described in MDCG 2022-16.
Frequently asked questions
Does a class I device really need an EU authorized representative?
Yes. Article 11(1) is triggered by where the manufacturer is established, not by the device class. Class I is the case where the authorized representative is the only EU-side appointment you must make.
We have a notified body certificate. Do we still need one?
Yes. A notified body assesses conformity; an authorized representative carries the Article 11(3) tasks and is the point of contact for competent authorities. They are different roles and neither replaces the other.
What do "Ir", "Is" and "Im" mean?
Shorthand for a class I device that carries one of the three limited procedures in Article 52(7) — reusable surgical instruments, sterile, or measuring function. The Regulation itself writes only "class I".
Can our EU importer or distributor act as our representative?
The roles carry different and partly conflicting obligations, and the mandate brings Article 11(5) joint liability with it. Most importers and distributors decline once they read that paragraph.
How is the fee set?
By class, not by catalogue length. Send your device list and you will get one written number, a €0 setup fee, and rates fixed for three years.
How long does appointment take?
Once your file is complete, quickly. What takes time is the file — a missing biocompatibility report or an unvalidated reprocessing cycle, not the mandate itself.
Sources and further reading
Regulation (EU) 2017/745 (MDR), consolidated text — Article 11, Article 52(7), Annex VIII — EUR-Lex, CELEX 02017R0745-20230320
European Commission, health.ec.europa.eu — medical devices, EUDAMED
MDCG 2022-16; European Commission Notice to Stakeholders, March 2022
Get a fixed-price EU REP quote for your device range (reply within 1 business day). Send your device list and your declaration of conformity to our regulatory team. One written number, a €0 setup fee, rates fixed for three years. Request a proposal
Request a proposal · View pricing · Our EU REP service · By manufacturer country