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EU authorised representative cost

Most representatives quote only after a sales call. Our class-based rates are published so you can budget before making contact. Fees are in euros, exclude VAT, and are fixed for three years from signature.

These fees cover Article 11 authorised representative services only. Under the EU–Türkiye Customs Union the appointment is valid in both territories, so a second representative is not required. ÜTS registration consultancy is a separate service under a separate contract and is not included in the annual fee.

What drives the price. The class of your device sets the band, because the class sets how much documentation we have to hold and review and how exposed we are under Article 11(5). Within a band, what matters is the number of Basic UDI-DIs, not the number of catalogue numbers: one device equals one Basic UDI-DI, unlimited UDI-DI variants underneath it are covered, and the first ten UDI-DI entries are included. Nothing here is priced per hour and nothing is priced per e-mail.

What the annual fee includes. Article 11(3) representation for every device under the mandate, EUDAMED actor registration and your SRN, device and UDI records, the mandate record linking your company to ours, holding your technical documentation and EU declaration of conformity at the disposal of competent authorities, and acting as your contact point. Competent authority requests are acknowledged within one business day.

What it does not include. Conformity assessment and notified body fees. Drafting your technical documentation. ÜTS registration consultancy, which runs under a separate contract. And any fee a competent authority charges you directly: Article 31(8) allows a competent authority to use your registration data to "charge the manufacturer, the authorised representative or the importer a fee pursuant to Article 111". That is a state fee, not ours, and we do not mark it up.

Changing representative costs EUR 150. Article 12 requires the arrangements to be set out in an agreement between you, the outgoing representative and the incoming one, and it fixes what that agreement must cover: the date the outgoing mandate ends and the new one begins, the date until which the outgoing representative may still be named in your material including promotional material, the transfer of documents with confidentiality and property rights addressed, and the outgoing representative's continuing duty to forward complaints and incident reports after the mandate has ended. We draft and run that agreement as part of the EUR 150.

The rate you sign is fixed for three years from signature. If your device count grows within a class, the band does not move.

Medical devices  MDR 2017/745

Class I

€800 – 1,000 per year

Class IIa

€1,000 – 1,300 per year

Class IIb

€1,200 – 1,600 per year

Class III 

€1,500 – 2,000 per year

In vitro diagnostics
IVDR 2017/746

Class A

€800 – 1,000 per year

Class B

€1,000 – 1,300 per year

Class C

€1,200 – 1,600 per year

Class D

€1,500 – 2,000 per year

Additional items

Setup

€0. No setup fee.

Change of representative

€150. Article 12 handover.

Appoint a representative

Send your device list for a written quote

Device class
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