Competent Authority Requests: What Your EU Authorised Representative Must Provide

When a national competent authority in the Union has a question about a device made outside the Union, the letter does not go to the factory. It goes to the authorised representative named on the label and in EUDAMED. For a manufacturer established outside the Union, that representative is the authority's only guaranteed point of contact in the European market, and the MDR sets out in some detail what it must be able to hand over, how fast, and in which language. This article walks through those obligations in the order an authority request usually arrives: documents, samples, evaluation, corrective action.

What a competent authority is entitled to check

Market surveillance under the MDR is not limited to devices that have already caused harm. Article 93(1) gives the authorities a general mandate to check devices on the market:

"The competent authorities shall perform appropriate checks on the conformity characteristics and performance of devices including, where appropriate, a review of documentation and physical or laboratory checks on the basis of adequate samples."

Article 93(3) then gives them the means to do it. The first power is the one an authorised representative meets most often:

"(a) may require economic operators to, inter alia, make available the documentation and information necessary for the purpose of carrying out the authorities' activities and, where justified, to provide the necessary samples of devices or access to devices free of charge;"

The authorised representative is an economic operator under the MDR. A request under Article 93 can therefore be addressed to it directly, and it frequently is, because the representative is the operator whose registered place of business is in the Union and whose details the authority can find in EUDAMED in a few seconds.

The representative's duty to answer

The mandate between the manufacturer and the representative is not free to leave this out. Article 11(3) lists the tasks every mandate must cover, and point (d) is the one that turns an authority's letter into a deadline:

"(d) in response to a request from a competent authority, provide that competent authority with all the information and documentation necessary to demonstrate the conformity of a device, in an official Union language determined by the Member State concerned;"

Three details in that sentence matter in practice. The obligation is to provide "all the information and documentation necessary", not a summary chosen by the manufacturer. The purpose is to "demonstrate the conformity of a device", so the authority decides what is relevant to its question. And the language is set by the Member State, not by the manufacturer: a technical file kept only in Chinese, Korean or Portuguese does not meet the request, and a translation arranged after the letter arrives is a translation arranged under time pressure.

The manufacturer carries the same obligation in its own name. Article 10(14) provides that manufacturers "shall, upon request by a competent authority, provide it with all the information and documentation necessary to demonstrate the conformity of the device, in an official Union language determined by the Member State concerned." The two duties run in parallel. The representative does not replace the manufacturer; it makes sure the answer can be given from inside the Union.

Why the documents have to be in the Union before anyone asks

A representative cannot answer point (d) with documents it does not hold. The MDR closes that gap on both sides. On the representative's side, Article 11(3)(b) requires it to keep a copy of the technical documentation, the EU declaration of conformity and any certificate at the disposal of the competent authorities. On the manufacturer's side, the last sentence of Article 10(8) is explicit:

"A manufacturer with a registered place of business outside the Union shall, in order to allow its authorised representative to fulfil the tasks mentioned in Article 11(3), ensure that the authorised representative has the necessary documentation permanently available."

"Permanently available" is the operative phrase. A link to a folder that the manufacturer can revoke, or a promise to send the file when needed, does not meet it. The same article fixes how long the documentation must remain available: at least 10 years after the last device covered by the declaration of conformity has been placed on the market, and at least 15 years for implantable devices. A mandate that ends earlier does not end the manufacturer's obligation; it only changes who holds the copy.

Samples and access to the device

Documentation is often not enough for a market surveillance check. Where an authority wants to test the device itself, Article 11(3)(e) gives the representative a specific role:

"(e) forward to the manufacturer any request by a competent authority of the Member State in which the authorised representative has its registered place of business for samples, or access to a device and verify that the competent authority receives the samples or is given access to the device;"

The representative does not manufacture samples, but it is responsible for making sure the request reaches the manufacturer and that the authority actually receives what it asked for. Under Article 93(3)(a), samples requested for market surveillance are provided free of charge where the request is justified. A manufacturer that plans for this, for example by keeping a small reserve of each device family in the Union or by agreeing a shipping route in advance, avoids a request stalling in customs.

From evaluation to corrective action

If the documents or samples raise a concern, the authority moves to a formal evaluation. Article 94 sets the trigger and ends with a sentence that applies to every economic operator in the chain:

"The relevant economic operators shall cooperate with the competent authorities."

Where the evaluation shows an unacceptable risk, Article 95(1) names the representative expressly among those who must act. The authorities "shall without delay require the manufacturer of the devices concerned, its authorised representative and all other relevant economic operators to take all appropriate and duly justified corrective action to bring the device into compliance with the requirements of this Regulation relating to the risk presented by the device", and, in proportion to the risk, to restrict, condition, withdraw or recall the device within a period the authority defines. Article 95(3) extends the obligation across the whole Union market:

"The economic operators as referred to in paragraph 1 shall, without delay, ensure that all appropriate corrective action is taken throughout the Union in respect of all the devices concerned that they have made available on the market."

This is why Article 11(3)(f) requires the mandate to oblige the representative to "cooperate with the competent authorities on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices;". In practice the representative coordinates the Union side of a corrective action: it receives the authority's requirement, confirms what the manufacturer will do and by when, and reports back.

Non-compliance without an unacceptable risk

Not every finding is a safety case. A missing element in the declaration of conformity, a label without the representative's details, or an out-of-date registration record can make a device non-compliant without making it dangerous. Article 97(1) deals with that situation separately. Where the device "does not comply with the requirements laid down in this Regulation but does not present an unacceptable risk", the authority "shall require the relevant economic operator to bring the non-compliance concerned to an end within a reasonable period that is clearly defined and communicated to the economic operator and that is proportionate to the non-compliance." The period is short but workable, provided the representative can reach the manufacturer and the manufacturer can produce the corrected document.

When the manufacturer does not cooperate

The MDR gives the authority a direct remedy if the answer never comes. Under Article 10(14), where the manufacturer fails to cooperate or the information provided is incomplete or incorrect, the competent authority may take all appropriate measures to prohibit or restrict the device's being made available on its national market, to withdraw it or to recall it until the manufacturer cooperates or provides complete and correct information.

The representative has its own line as well. Point (h) of Article 11(3) requires the mandate to allow it to "terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation." Under Article 11(5), a representative also carries joint and several liability for defective devices where a manufacturer outside the Union has not complied with Article 10. A representative that cannot obtain the documents it needs to answer an authority is therefore not only in breach of its mandate but exposed in its own right, which is why serious representatives treat an unanswered request as a reason to end the relationship.

A practical checklist for manufacturers outside the Union

• Make sure your representative already holds the current technical documentation, the EU declaration of conformity and any certificate, including amendments and supplements, and that it will keep holding them for 10 years after the last device is placed on the market, or 15 years for implantable devices.

• Agree in the mandate which official Union language the documentation can be provided in quickly, and who pays for translation when a Member State asks for a different language.

• Name a person at your company who answers the representative within a fixed time, and a deputy for holidays.

• Keep a small reserve of samples for each device family, or agree in advance how samples will be shipped to a Union authority free of charge.

• Keep your EUDAMED actor data, device registrations and label details consistent with each other. An authority that finds three different addresses will ask why.

• Decide before any request arrives how a corrective action would be carried out in the Union, and who would inform distributors and importers.

How we handle an authority request as your representative

As an authorised representative registered in EUDAMED under SRN TR-AR-000057550, we treat a competent authority request as the most time-critical event in a mandate. We acknowledge the request to the authority, forward it to your named contact the same day, prepare the answer from the documentation we already hold, and confirm to the authority what has been provided and when. Where samples or access are requested, we follow the request through until the authority confirms receipt. If you are appointing a representative now, or reviewing whether your current one could answer such a letter within days rather than weeks, you can request a proposal and we will set out in writing how we would handle it for your devices.

The IVDR contains equivalent provisions for in vitro diagnostic medical devices, so the same approach

applies to IVD manufacturers.