EU Authorized Representative for In Vitro Diagnostic Reagent and Test Kit Manufacturers

When a reagent or kit is an IVD under the IVDR

The IVDR covers reagents, calibrators, control materials, kits, instruments, software and specimen receptacles intended to be used in vitro for the examination of specimens derived from the human body. The decisive element is the manufacturer's stated purpose, not the chemistry. The definition in Article 2(2) lists the information the device must provide, including information:

"concerning a physiological or pathological process or state" (IVDR Article 2(2)(a))

Products labelled for research use only sit outside the Regulation, but only within the limit set by Article 1(3)(a):

"products for general laboratory use or research-use only products, unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination" (IVDR Article 1(3)(a))

A kit shipped with an "RUO" label but supplied with clinical cut-offs, a diagnostic claim in the instructions or promotion to clinical laboratories is not an RUO product for the purposes of this provision.

Classification under Annex VIII: seven rules, four classes

Annex VIII applies to the intended purpose of each device. Two implementing rules decide most disputes before any classification rule is read:

"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." (IVDR Annex VIII, Section 1.8)

"Calibrators intended to be used with a device shall be classified in the same class as the device." (IVDR Annex VIII, Section 1.5)

Rule 1 places in class D devices for screening blood, tissue and organ donations for transmissible agents, and devices for transmissible agents that cause a life-threatening disease with a high or suspected high risk of propagation. Rule 2 covers blood grouping and tissue typing (class C, or class D for the listed ABO, Rhesus, Kell, Kidd and Duffy markers). Rule 3 is the rule most reagent portfolios fall under:

"Devices are classified as class C if they are intended: (a) for detecting the presence of, or exposure to, a sexually transmitted agent;" (IVDR Annex VIII, Rule 3)

Rule 3 continues through points (b) to (m), including companion diagnostics, human genetic testing, and devices used "in screening, diagnosis, or staging of cancer" (point (h)). Self-testing has its own rule:

"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." (IVDR Annex VIII, Rule 4(a))

A device for self-testing is defined in Article 2(5) as one "intended by the manufacturer to be used by lay persons". Rule 5 lists the class A devices, and Rule 6 is the residual rule:

"Devices not covered by the above-mentioned classification rules are classified as class B." (IVDR Annex VIII, Rule 6)

The glucose strip and HIV self-test rows follow the examples in MDCG 2020-16 rev.5 (September 2026), which also notes that a self-testing HIV device is class D through Rule 1 and implementing rule 1.9. Controls follow the device when they carry assigned values (Section 1.6); controls without an assigned value are class B under Rule 7.

Conformity routes by class

Article 48 sets the procedure for each class. For class A the manufacturer declares conformity on its own, with one exception:

"However, if those devices are placed on the market in sterile condition, the manufacturer shall apply the procedures set out in Annex IX or in Annex XI. Involvement of the notified body shall be limited to the aspects relating to establishing, securing and maintaining sterile conditions." (IVDR Article 48(10))

Class B and class C devices undergo quality management system assessment under Chapters I and III of Annex IX with technical documentation assessment on a representative basis: per category of devices for class B (Article 48(9)) and per generic device group for class C (Article 48(7)). Self-tests and near-patient tests add a technical documentation assessment under Section 5.1 of Annex IX. Class D follows Article 48(3) or (4), with EU reference laboratory testing where a laboratory has been designated and, in the cases set out in Article 48(6), expert panel consultation. Companion diagnostics require consultation of the medicines authority or the EMA.

Legacy IVDD devices after Regulation (EU) 2024/1860

Most reagents that were self-declared under Directive 98/79/EC now need a notified body. Regulation (EU) 2024/1860 amended Article 110 and set staggered end dates for these devices:

"(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." (IVDR Article 110(3b))

These dates apply only if the conditions of Article 110(3c) are met: continued compliance with the Directive, no significant change in design or intended purpose, a quality management system under Article 10(8) by 26 May 2025, a formal notified body application, and a signed written agreement. For class C legacy devices the application date was 26 May 2026 and the agreement date 26 September 2026. For class B and sterile class A legacy devices, the application must be lodged by 26 May 2027 and the agreement signed by 26 September 2027. Devices holding a valid IVDD certificate may be placed on the market until 31 December 2027 under Article 110(3a). Under Article 110(3d), IVDR requirements on post-market surveillance, vigilance and registration of economic operators and devices apply to legacy devices in place of the Directive's requirements, so the authorised representative's IVDR tasks already apply to them.

Regulation (EU) 2024/1860 also inserted Article 10a, which requires the manufacturer to inform the competent authority of the Member State where it or its authorised representative is established of an anticipated interruption or discontinuation of supply that could result in serious harm, as a rule at least six months in advance.

The Article 11 mandate for IVD manufacturers

The obligation to designate a representative does not depend on class:

"Where the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if the manufacturer designates a sole authorised representative." (IVDR Article 11(1))

The mandate covers at least all devices of the same generic device group (Article 11(2)). Under Article 11(3), the representative must verify that the EU declaration of conformity and technical documentation have been drawn up and that the conformity assessment has been carried out, keep that documentation and any certificate available to competent authorities, handle registration under Articles 26 and 28, forward complaints and incident reports, and cooperate on corrective action. Where the manufacturer has not complied with Article 10, Article 11(5) makes the representative jointly and severally liable for defective devices, which is why the verification step is carried out with care.

What Medex does under the mandate

Medex Kurumsal Danışmanlık is registered in EUDAMED as authorised representative under SRN TR-AR-000057550. Our person responsible for regulatory compliance is in-house. Under the IVDR mandate we:

review your classification per device against Annex VIII and check that the declared conformity route matches it;

verify the EU declaration of conformity, the technical documentation index and, for classes B to D and sterile class A, the notified body certificate;

register the representative link in EUDAMED and check your device registrations;

keep the documentation available to competent authorities and answer their requests;

forward complaints and incident reports and support field safety corrective actions.

Under the EU–Türkiye Customs Union, the Commission Notice of March 2022 states that manufacturers outside the EU and Türkiye "only need to designate one authorised representative, either in the EU or in Turkey". One Medex mandate therefore covers both markets. We work from Ankara, İstanbul and Gdańsk. Annual fees range from €800 for class A to €2,000 for class D, with no setup fee and €150 for a change of representative. Medex does not write technical documentation or performance evaluations, is not a notified body, does not find distributors, and cannot act as CH-REP or UK Responsible Person.

Related device categories and country pages

We keep separate pages for other device groups, including continuous glucose monitors, examination and surgical gloves and condoms. All groups are listed on the medical device categories page. Most of the manufacturers we represent are based in China, Türkiye, India and South Korea; the full list is on the EU authorized representative by country page. We also cover medical device software.

To check how IVDR Annex VIII applies to your own assay, use our free IVDR classification checker. It covers rules 1 to 7 and quotes the rule text behind every result.

If your device is still placed on the market under an MDD, AIMDD or IVDD certificate or declaration, the free MDR and IVDR transition deadline checker shows the Article 120 or Article 110 date that applies and the conditions it depends on.

Frequently asked questions

Does a class A reagent manufacturer need an EU authorized representative?

Yes. Article 11(1) of the IVDR applies to every manufacturer not established in a Member State, whatever the class. Class A only changes the conformity route, not the representation requirement.

Is a professional-use rapid test classified the same as its self-test version?

Not necessarily. Rule 4(a) classifies self-tests as class C unless listed as an exception, while near-patient tests are classified in their own right under Rule 4(b). A pregnancy self-test is class B; a professional urine dipstick is class B under Rule 6.

Our IVDD kit was self-declared. Can it stay on the market?

Only if the conditions of Article 110(3c) are met, including a formal notified body application and a signed agreement by the dates for its IVDR class. The end dates are 31 December 2027, 2028 or 2029 for class D, C, and B or sterile class A.

Can we appoint one representative for the EU and Türkiye?

Yes. Under the Commission Notice of March 2022 on the EU–Türkiye Customs Union, a manufacturer outside both only needs one authorised representative, either in the EU or in Türkiye.

Sources

Regulation (EU) 2017/746 on in vitro diagnostic medical devices, consolidated text 10.01.2025 — eur-lex.europa.eu

Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 and (EU) 2017/746 — eur-lex.europa.eu

MDCG 2020-16 rev.5, Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 (September 2026) — health.ec.europa.eu

MDCG endorsed guidance documents — health.ec.europa.eu

European Commission, Notice to Stakeholders: EU-Turkey Customs Union Agreement in the field of medical devices (March 2022) — health.ec.europa.eu

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Other device categories

We also cover dental devices, wound dressings, reusable surgical instruments, condoms and wheelchairs and mobility aids. The full list is on the device categories page, and country pages are in the list by country.

If your devices still need to be registered in EUDAMED, see our EUDAMED registration proposal.