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 Classification Checker: Annex VIII Rules 1 to 22

Regulation (EU) 2017/745 sorts medical devices into classes I, IIa, IIb and III using the 22 rules of Annex VIII. The class decides whether a notified body is involved, which conformity assessment route applies and how much documentation you need before CE marking. This free checker walks through the rules for your device's intended purpose and, as Annex VIII Section 3.5 requires, returns the strictest class that applies.

Every result quotes the rule text from the official EUR-Lex consolidated version of the MDR, so you can see exactly why the device lands in its class. The result is indicative: classification remains the manufacturer's responsibility and, for classes Is, Im, Ir, IIa, IIb and III, the notified body reviews it. For borderline products, MDCG 2021-24 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.

How Annex VIII works

Article 51(1) of the MDR sets the frame: "Devices shall be divided into classes I, IIa, IIb and III, taking into account the intended purpose of the devices and their inherent risks. Classification shall be carried out in accordance with Annex VIII."

Annex VIII has three chapters: definitions specific to classification (duration of use, invasiveness, active devices), implementing rules, and the 22 classification rules. The rules are grouped as non-invasive devices (Rules 1 to 4), invasive devices (Rules 5 to 8), active devices (Rules 9 to 13) and special rules (Rules 14 to 22), which cover devices incorporating medicinal substances, contraceptives, disinfecting products, nanomaterials and products without an intended medical purpose.

The implementing rules that change the answer

Section 3.1: "Application of the classification rules shall be governed by the intended purpose of the devices." The label, the instructions for use and the promotional material are read together. A claim added to a brochure can move a device into a higher class.

Section 3.2, on accessories: "Accessories for a medical device shall be classified in their own right separately from the device with which they are used."

Section 3.3, on software: "Software, which drives a device or influences the use of a device, shall fall within the same class as the device. If the software is independent of any other device, it shall be classified in its own right." Standalone software is usually assessed under Rule 11, covered in our note on medical device software and Rule 11.

Section 3.5, which this checker applies to every result: "If several rules, or if, within the same rule, several sub-rules, apply to the same device based on the device's intended purpose, the strictest rule and sub-rule resulting in the higher classification shall apply."

Duration of use

Many invasive device rules turn on how long the device stays in use. Section 1 of Annex VIII defines the three periods: "'Transient' means normally intended for continuous use for less than 60 minutes." "'Short term' means normally intended for continuous use for between 60 minutes and 30 days." "'Long term' means normally intended for continuous use for more than 30 days."

Class I is not a single route

Article 52(7) separates plain class I devices from the three subclasses: "If those devices are placed on the market in sterile condition, have a measuring function or are reusable surgical instruments, the manufacturer shall apply the procedures set out in Chapters I and III of Annex IX, or in Part A of Annex XI." For those devices the notified body looks only at sterility, metrology or reuse. Plain class I devices are self-declared, but the quality management system is still required; see class I medical devices and the Article 10(9) QMS for class I.

When the manufacturer and the notified body disagree

Article 51(2): "Any dispute between the manufacturer and the notified body concerned, arising from the application of Annex VIII, shall be referred for a decision to the competent authority of the Member State in which the manufacturer has its registered place of business." The same paragraph sets the route for manufacturers without a registered place of business in the Union.

For a worked walk-through of the rules with examples, read our guide to medical device classification under Annex VIII. If your device was certified under the Directives, the transition deadline checker shows how long it may stay on the market.