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.

IVDR Classification Checker: Annex VIII Rules 1 to 7

Regulation (EU) 2017/746 sorts in vitro diagnostic medical devices into classes A, B, C and D using the seven rules of Annex VIII. Under the IVDR most IVDs need a notified body for the first time, so the class decides the conformity assessment route, the documentation depth and the timeline. This free checker walks through the rules for your IVD's intended purpose and, as Annex VIII Section 1.9 requires, returns the higher class when several rules apply.

Every result quotes the rule text from the official EUR-Lex consolidated version of the IVDR. The result is indicative: classification remains the manufacturer's responsibility and, for classes A sterile, B, C and D, the notified body reviews it. Calibrators and controls with assigned values take the class of the device they are used with, and MDCG 2020-16 gives the Commission's worked examples.

Manufacturers established outside the European Union also need an authorised representative under Article 11 before the first device is placed on the market. Medex acts as EU authorised representative from Türkiye under the EU-Türkiye Customs Union, registered in EUDAMED under SRN TR-AR-000057550. For general medical devices, use our MDR classification checker.

How IVDR classification works

Article 47(1) of the IVDR: "Devices shall be divided into classes A, B, C and D, taking into account the intended purpose of the devices and their inherent risks. Classification shall be carried out in accordance with Annex VIII."

The implementing rules

Section 1.1: "Application of the classification rules shall be governed by the intended purpose of the devices."

Sections 1.5 and 1.6 keep calibrators and controls with the assay they support: "Calibrators intended to be used with a device shall be classified in the same class as the device." "Control materials with quantitative or qualitative assigned values intended for one specific analyte or multiple analytes shall be classified in the same class as the device."

Section 1.8: "Where a manufacturer states multiple intended purposes for a device, and as a result the device falls into more than one class, it shall be classified in the higher class." Section 1.10 adds that "Each of the classification rules shall apply to first line assays, confirmatory assays and supplemental assays."

The seven rules at a glance

Rule 1 places in class D the devices that screen blood, cells, tissues or organs for transmissible agents, detect agents that cause a life-threatening disease with a high risk of propagation, or determine the infectious load where monitoring is critical. Rule 2 places blood grouping and tissue typing in class C, with the listed blood group markers moved to class D. Rule 3 lists the class C purposes, among them sexually transmitted agents, companion diagnostics, cancer screening, diagnosis or staging, human genetic testing and congenital disorder screening.

Rule 4(a): "Devices intended for self-testing are classified as class C, except for devices for the detection of pregnancy, for fertility testing and for determining cholesterol level, and devices for the detection of glucose, erythrocytes , leucocytes and bacteria in urine, which are classified as class B." Rule 5 covers class A: products for general laboratory use, instruments intended specifically for IVD procedures, and specimen receptacles. Rule 6 is the residual rule: "Devices not covered by the above-mentioned classification rules are classified as class B." Rule 7 puts controls without an assigned value in class B.

For the full reasoning with examples, read our note on IVDR classification under Annex VIII. Class B, C and D devices then need a notified body and a performance evaluation under Annex XIII. For the representative role under the IVDR, see the IVDR authorised representative.