EU Authorized Representative for Medical Device Software Manufacturers: Qualification, Rule 11 and the Mandate

When software is a medical device

The MDR definition of a medical device names software explicitly and turns on the manufacturer's intended purpose:

"‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:" (MDR Article 2(1))

The first listed purpose is the one most software relies on:

"— diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease," (MDR Article 2(1))

Software that only records, stores or displays data is generally not a device. MDCG 2021-24 Rev.1 gives the example of software analogous to diaries for recording insulin doses, which would not be considered a device "unless an analysis is performed on the data or the device in some way alters the patients treatment, prescription, doses etc." The detailed qualification criteria are set out in MDCG 2019-11.

The MDR also deems software to be an active device:

"Software shall also be deemed to be an active device;" (MDR Article 2(4))

This matters for classification, because the rules for active devices, and Rule 11 in particular, then apply.

Rule 11: how software is classified

Rule 11 sets the class by the significance of the information the software provides and by the condition of the patient:

"Rule 11 Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes is classified as class IIa, except if such decisions have an impact that may cause: — death or an irreversible deterioration of a person's state of health, in which case it is in class III; or — a serious deterioration of a person's state of health or a surgical intervention, in which case it is classified as class IIb." (MDR Annex VIII, Rule 11)

The rule continues with monitoring software and a residual class:

"Software intended to monitor physiological processes is classified as class IIa, except if it is intended for monitoring of vital physiological parameters, where the nature of variations of those parameters is such that it could result in immediate danger to the patient, in which case it is classified as class IIb. All other software is classified as class I." (MDR Annex VIII, Rule 11)

Software that drives hardware is not classified on its own:

"3.3. 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." (MDR Annex VIII, Section 3.3)

Examples from MDCG 2021-24 Rev.1

MDCG 2021-24 Rev.1 adds that software should be classified in the same way regardless of where it runs or how it connects to hardware, and that the intended population and context of use, such as intensive care or home use, must be taken into account.

What the manufacturer needs before placing software on the market

For class I software, Article 52(7) allows a declaration of conformity after the technical documentation of Annexes II and III is drawn up. For class IIa and above, a notified body assesses the quality management system and, depending on the route, the technical documentation.

The technical documentation of medical device software normally covers the software life cycle, risk management, usability, cybersecurity and the clinical evaluation of the claimed performance. EN ISO 14971:2019 on risk management and EN ISO 13485:2016 on quality management systems are cited as harmonised standards under the MDR. EN 62304 on software life cycle processes is widely used as the state of the art but did not appear in the Commission's summary list of harmonised standards for the MDR generated on 17 June 2026.

The software also needs a Basic UDI-DI and a UDI-DI. Annex VI Part C, Section 6.5.2 requires a new UDI-DI whenever a modification changes the original performance, the safety or intended use of the software, or the interpretation of data; minor revisions need only a new UDI-PI. It must be registered in EUDAMED under Article 29, and the manufacturer must have a person responsible for regulatory compliance available under Article 15.

Distribution through app stores

An app downloaded by users in a Member State is made available on the Union market, even when the manufacturer has no office, server or distributor in the EU. Article 11(1) is not limited to physical products:

"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." (MDR Article 11(1))

Distance sales are addressed directly in Article 6:

"1. A device offered by means of information society services, as defined in point (b) of Article 1(1) of Directive (EU) 2015/1535, to a natural or legal person established in the Union shall comply with this Regulation." (MDR Article 6(1))

The name and address of the authorised representative must appear in the device labelling, which for software is normally provided in electronic form within the application.

What Medex does under the mandate

Medex Kurumsal Danışmanlık acts as authorised representative under EUDAMED SRN TR-AR-000057550. Under the mandate we verify that the EU declaration of conformity and technical documentation have been drawn up and, for class IIa and above, that the notified body procedure has been carried out; keep copies at the disposal of competent authorities; complete our own actor registration and check your UDI and device registrations; forward authority requests; cooperate on corrective actions, including software field safety corrective actions; and pass on complaints and incident reports without delay. A person responsible for regulatory compliance is available in-house, as Article 15(6) requires.

The European Commission's Notice of March 2022 confirms that manufacturers outside the EU and Türkiye "only need to designate one authorised representative, either in the EU or in Turkey", so one Medex mandate covers both markets. Offices in Ankara, İstanbul and Gdańsk.

Annual fees range from €800 for class I to €2,000 for class III, with a €0 setup fee and €150 for a change of representative. We do not write technical documentation, software documentation or clinical evaluations, we are not a notified body, and we do not find distributors or act as a Swiss or UK representative. We reply within one business day.

Related device categories and country pages

We keep separate pages for other device groups, including continuous glucose monitors, IVD reagents and test kits and spectacle frames and ophthalmic optics. 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.

To check how Annex VIII applies to your own device, use our free MDR classification checker. It walks through rules 1 to 22 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

Our app only stores and displays readings from a device. Is it a medical device?

Generally not, if it only records, stores or displays data without analysis that alters treatment, prescription or doses. MDCG 2021-24 Rev.1 and MDCG 2019-11 describe where that line sits. Any analysis feature that informs a diagnostic or therapeutic decision brings the software within the definition.

Can medical device software be class I under the MDR?

Yes, when it neither provides information used for diagnostic or therapeutic decisions nor monitors physiological processes. MDCG 2021-24 Rev.1 gives a fertility calculation app as a class I example. Most decision-support and monitoring software is class IIa or higher.

We sell our app only through app stores. Do we still need an EU authorised representative?

Yes. Making the software available to users in the Union is placing it on the market, and Article 11(1) applies to every manufacturer not established in a Member State, whatever the distribution channel.

Does one mandate cover the European Union and Türkiye?

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

Sources

Regulation (EU) 2017/745 on medical devices, consolidated text — eur-lex.europa.eu

MDCG 2021-24 Rev.1, Guidance on classification of medical devices (April 2026) — health.ec.europa.eu

MDCG 2019-11, Guidance on qualification and classification of software in Regulation (EU) 2017/745 and Regulation (EU) 2017/746 — health.ec.europa.eu

European Commission, Summary list of harmonised standards (Regulation (EU) 2017/745) — single-market-economy.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 examination and surgical gloves, kinesiology tape, in vitro diagnostic reagents, dental devices and wound dressings. 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.