EU authorised representative fees

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.

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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.

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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.

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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.

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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.

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

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A worked example. A class I manufacturer with three Basic UDI-DIs pays one annual fee inside the class I band of €800 – 1,000, and no setup fee. Adding a fourth class I Basic UDI-DI later does not move the band. A fee charged directly by a competent authority under Article 111 is paid to that authority and is not part of our fee.

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Frequently asked questions

How much does an EU authorised representative cost with Medex?

Between €800 and €2,000 per year, depending on the class of the device, with no setup fee. The bands are published on this page and are fixed for three years from signature.

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Is the fee charged per device or per manufacturer?

The class of the device sets the band. Within the band, the number of Basic UDI-DIs is what counts; catalogue numbers and UDI-DI variants under one Basic UDI-DI do not multiply the fee.

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Does one appointment cover the EU and Türkiye?

Yes. Medex is established in Türkiye, and under the EU–Türkiye Customs Union a manufacturer established outside both territories designates one authorised representative, either in the EU or in Türkiye, for both markets.

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Can you also act as our UK Responsible Person or Swiss representative?

No. Great Britain and Switzerland require representatives established there. Our mandate covers the EU Member States and Türkiye.

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What does it cost to move to Medex from another representative?

€150. Article 12 sets what the handover agreement must cover, and we draft and run that agreement for you.