Authorised Representative in GreMDIS: What EOF Means — and What It Does Not

When registering medical devices in GreMDIS, the national registry of the National Organization for Medicines (EOF), companies must declare their regulatory role accurately. One of the most frequent sources of confusion is the term Authorised Representative (εξουσιοδοτημένος αντιπρόσωπος).

In everyday commercial language, companies often speak of an exclusive representative (αποκλειστικός αντιπρόσωπος) or full representation (πλήρη αντιπροσώπευση), covering import, distribution, and service. These are commercial descriptions. In GreMDIS and under EU medical device law, they are not the same as Authorised Representative.

This article explains what EOF/GreMDIS means by Authorised Representative, cites the exact legal wording, and clarifies how it differs from other roles you may encounter — including distributor, importer, and manufacturer.

Why This Matters in GreMDIS

GreMDIS (Greek Medical Devices Information System) is EOF's electronic registry for medical devices placed on the Greek market. Each notification must identify the economic operator performing the registration and their legal role in the supply chain.

Selecting the wrong role can lead to:

• incomplete or incorrect documentation
• rejection or correction requests from EOF
• inconsistency between GreMDIS, EUDAMED, and contractual arrangements with the manufacturer
• regulatory risk during inspections or market surveillance

The role you declare must reflect your legal obligations, not your commercial marketing description.

The Official Definition: «εξουσιοδοτημένος αντιπρόσωπος»

The term authorised representative originates in EU medical device law. In Greece, it was incorporated through Joint Ministerial Decision ΔΥ8δ/Γ.Π.οικ. 130648/30-08-2009 (published in Government Gazette ΦΕΚ 2198Β/2.10.2009), harmonizing national legislation with Directive 93/42/EEC on medical devices. Today, the same concept is carried forward at EU level in MDR (EU) 2017/745, Article 2(32). Article 2.1(ι) of the Greek decision defines the term as follows:

ι) «εξουσιοδοτημένος αντιπρόσωπος»: το εγκατεστημένο στην Κοινότητα φυσικό ή νομικό πρόσωπο, το οποίο, αφού οριστεί ρητά από τον κατασκευαστή, ενεργεί εξ ονόματός του και τον αντιπροσωπεύει έναντι των αρχών και των υπηρεσιών στην Κοινότητα, όσον αφορά στις υποχρεώσεις του κατασκευαστή που απορρέουν από την παρούσα απόφαση.

English translation:

i) "authorised representative": the natural or legal person established within the Community who, having been explicitly appointed by the manufacturer, acts on their behalf and represents them before the authorities and services in the Community, regarding the manufacturer's obligations arising from this decision.

Key characteristics

An Authorised Representative is:

• a legally appointed party, not a self-declared commercial agent
• established within the EU
• acting on behalf of a manufacturer — typically one established outside the EU
• responsible for regulatory representation before competent authorities
• bound by a written mandate defining the tasks delegated by the manufacturer

An Authorised Representative is not automatically an importer, distributor, or exclusive commercial agent — even if the same company performs several of these functions in practice.

Terms That Are Often Confused

«Αποκλειστικός αντιπρόσωπος» (Exclusive Representative)

In commercial practice, an exclusive representative is a company granted exclusive rights to sell or promote a manufacturer's products in a territory. This is a commercial and contractual relationship.

It does not by itself confer the status of Authorised Representative in GreMDIS or under MDR/IVDR. Unless the company has also been formally appointed under a written mandate to fulfil the manufacturer's regulatory obligations, it should not be registered as Authorised Representative.

«Πλήρη αντιπροσώπευση» (Full Representation)

Companies frequently advertise full representation, meaning they handle import, distribution, and after-sales service for a product line. This is common in the Greek medical device market and describes the scope of commercial operations, not a single regulatory role.

In this type of wording, full representation describes a bundle of commercial activities. In GreMDIS, the same company might need to register separately as importer and/or distributor, depending on its actual role in the supply chain — and would only be Authorised Representative if formally mandated by a non-EU manufacturer for that regulatory function.

Other Roles in GreMDIS

GreMDIS distinguishes between several economic operator roles in the medical device supply chain:

Role in GreMDIS	Greek term	What it means
Manufacturer	Κατασκευαστής	The entity that manufactures or fully refurbishes the device, or has it designed/manufactured and markets it under its own name
Authorised Representative	Εξουσιοδοτημένος αντιπρόσωπος	EU-established entity mandated by a non-EU manufacturer to act on its behalf for regulatory obligations
Importer	Εισαγωγέας	EU-established entity that places a device from a third country on the EU market
Distributor	Διανομέας	Any entity in the supply chain, other than the manufacturer or importer, that makes a device available on the market

Each role carries distinct regulatory obligations. A single company may hold more than one role for the same product — for example, acting as both importer and distributor — but in GreMDIS the role declared must match the capacity in which the notification is submitted.

Unlike EUDAMED, which covers manufacturers, authorised representatives, and importers but not distributors, GreMDIS is a national registry that also includes distributors. In Greece, economic operators — including distributors — must ensure that the medical devices they place on the market are registered in GreMDIS before distribution. This national requirement supports EOF's market surveillance and traceability obligations.

How We Can Help

At QC Analytics, we support organizations across the full regulatory registration cycle — from EOF/GreMDIS and EUDAMED to UDI/GS1 implementation. We can help you:

• determine the correct economic operator role for your GreMDIS submissions
• review Authorised Representative mandates and supporting documentation
• prepare and submit product notifications with complete, consistent data
• align national (EOF) and European (EUDAMED) registrations

For details on our services, see our EOF, EUDAMED, GS1 page. For guidance on your registrations, contact us.