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.

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.

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.

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.

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.

MDR and IVDR Transition Deadline Checker

Regulations (EU) 2023/607 and 2024/1860 extended the transition periods for legacy devices: medical devices certified or self-declared under Directive 93/42/EEC or 90/385/EEC, and in vitro diagnostics under Directive 98/79/EC. The new dates run to 31 December 2027, 2028 or 2029 depending on the class, but only for devices that meet every condition in MDR Article 120(3c) or IVDR Article 110(3c).

This free checker asks for the legacy basis, the class and the conditions, then shows the date that applies and quotes the article text from the official EUR-Lex consolidated versions. If a condition is missing, such as the quality management system, the formal application to a notified body or the signed written agreement, it tells you which one. The result is indicative and does not replace a check of your certificates and notified body agreement.

Legacy devices still need an authorised representative when the manufacturer is established outside the European Union. Medex acts as EU authorised representative from Türkiye under the EU-Türkiye Customs Union, registered in EUDAMED under SRN TR-AR-000057550. To classify a device first, use our MDR or IVDR classification checker.

The MDR dates

Article 120(3a) of the MDR, as amended by Regulation (EU) 2023/607, covers devices with a Directive certificate: "(a) 31 December 2027, for all class III devices, and for class IIb implantable devices except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors;" "(b) 31 December 2028, for class IIb devices other than those covered by point (a) of this paragraph, for class IIa devices, and for class I devices placed on the market in sterile condition or having a measuring function."

Article 120(3b) covers self-declared devices that need a notified body under the MDR: they "may be placed on the market or put into service until 31 December 2028."

The conditions in Article 120(3c)

The dates apply "only if the following conditions are met:"

"(a) those devices continue to comply with Directive 90/385/EEC or Directive 93/42/EEC, as applicable;"

"(b) there are no significant changes in the design and intended purpose;"

"(c) the devices do not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health;"

"(d) no later than 26 May 2024, the manufacturer has put in place a quality management system in accordance with Article 10(9);"

Point (e) requires a formal application to a notified body no later than 26 May 2024 and a signed written agreement no later than 26 September 2024.

The IVDR dates

Article 110(3a) of the IVDR, as amended by Regulation (EU) 2024/1860: devices with a certificate issued under Directive 98/79/EC "may be placed on the market or put into service until 31 December 2027." Under Article 110(3b), self-declared devices that need a notified body under the IVDR run to "(a) 31 December 2027, for class D devices; (b) 31 December 2028, for class C devices; (c) 31 December 2029, for class B devices and for class A devices placed on the market in sterile condition."

The IVDR conditions mirror the MDR ones, with a quality management system in place by 26 May 2025 and application deadlines staggered by class: 26 May 2025, 26 May 2026 and 26 May 2027.

What applies to legacy devices from day one

Legacy status is not a full exemption. Article 120(3d) of the MDR: "the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply to devices referred to in paragraphs 3a and 3b of this Article in place of the corresponding requirements in Directives 90/385/EEC and 93/42/EEC." That includes EUDAMED registration, covered in our note on legacy device registration in EUDAMED. The full timeline is in our note on the MDR transition period under Article 120.