Can customs seize a medical device shipment with no authorised representative?

Customs and other authorities designated under Article 25(1) of Regulation (EU) 2019/1020 suspend release for free circulation rather than seize. Article 26(1) lists the grounds, including incorrect labelling and any other cause to believe the product does not comply with Union law. Under Article 27 the suspension lapses after four working days unless a market surveillance authority asks for it to be maintained, and Article 28 allows outright refusal of release.

What penalties apply for placing a device on the EU market without an authorised representative?

There is no Union-level figure. MDR Article 113 leaves penalties to each Member State, requiring only that they be effective, proportionate and dissuasive, and that the rules be notified to the Commission. Amounts, procedure and whether liability is administrative or criminal therefore differ by Member State, and the same conduct can be sanctioned differently depending on where the enforcement case begins.

Can a non-EU manufacturer register in EUDAMED without an authorised representative?

No. A manufacturer established outside the Union submits its actor registration with the details and mandate dates of its authorised representative, and that representative must already be registered in EUDAMED and must verify the request before a competent authority validates it and issues the single registration number. Without a representative there is no SRN, and without an SRN there is no device or UDI registration.

Does appointing an authorised representative later fix a device already on the market?

It fixes the position going forward, not retrospectively. Devices already supplied were placed on the market in breach of Article 11(1) and remain non-compliant for the period concerned, so a competent authority can still act under Articles 94 and 97 and penalties under Article 113 remain available. Designation, relabelling and EUDAMED registration should be completed before further consignments are shipped.

Who does a competent authority contact if there is no EU authorised representative?

It contacts whoever it can reach inside the Union, which usually means the importer or distributor holding the stock, and it will address measures to them under Article 97 even though the underlying defect is the manufacturer's. Article 10(14) still obliges the manufacturer to supply conformity documentation on request, but the authority has no established Union addressee to serve, which tends to make measures faster and blunter.

No EU Authorised Representative: What Happens to Your Device in the Union

Q: Is a CE-marked device illegal in the EU if there is no EU authorised representative?

Yes, in the sense that it may not be placed on the Union market. MDR Article 11(1) makes designation of a sole authorised representative a condition of placing a device on the market where the manufacturer is not established in a Member State. The CE marking and the notified body certificate do not cure the omission; the device is treated as non-compliant under Article 94(b) and can be restricted, withdrawn or recalled under Article 97.

Q: Does Article 4 of Regulation (EU) 2019/1020 apply to medical devices?

No. Article 4(5) lists the legislation Article 4 covers, and Regulation (EU) 2017/745 is not among it. Recital 4 explains the reason: the Regulation applies only where there are no specific provisions with the same objective in Union harmonisation legislation. MDR Article 11 is that specific provision. Chapter VII of Regulation (EU) 2019/1020, on controls at the border, does apply to devices.

6 days ago

7 min read

A manufacturer established outside the European Union that ships devices into the Union with no EU authorised representative has not lawfully placed them on the market. They are non-compliant from the moment they are declared for release for free circulation: customs can suspend the consignment, a competent authority can require them withdrawn or recalled, penalties follow under national law, and the manufacturer cannot register in EUDAMED to correct the position afterwards. What follows is the mechanics: which text applies, who acts, and what happens to the goods.

What happens to a device shipped with no EU authorised representative

The starting point is Article 11(1) of Regulation (EU) 2017/745. Where a manufacturer 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 Art. 11(1)). The designation is not a formality bolted onto an otherwise compliant device; it is a condition on which placing on the market is permitted at all. A device that fails it is non-compliant, however good its technical documentation and whichever notified body certified it.

The omission is visible from the outside. Annex I, Chapter III, Section 23.2(d) requires the label to carry, "if the manufacturer has its registered place of business outside the Union, the name of the authorised representative and address of the registered place of business of the authorised representative" (MDR Annex I, 23.2(d)). A carton with no representative block is a labelling defect any inspector, importer or customs officer can see without opening a file. Whether the obligation reaches your product is answered in our note on whether you need an EU authorised representative.

How MDR Article 11 and Article 10(14) sit together

Article 11 does not move the manufacturer's own duties to the representative. Article 11(4) excludes the core Article 10 obligations from the mandate, and Article 10(14) keeps the manufacturer directly answerable: "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." (MDR Art. 10(14)).

The two are complementary. Article 10(14) says what must be produced; Article 11 says there must be a legal person inside the Union who can be reached and held to it — one who is, under Article 11(5), "legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer" (MDR Art. 11(5)) where the manufacturer has not complied with Article 10. Remove that person and the authority is left with an obligation owed by an entity outside its jurisdiction. The mandate itself is covered in our article on MDR Article 11.

Where Regulation (EU) 2019/1020 Article 4 fits, and where it does not

Article 4 of Regulation (EU) 2019/1020 on market surveillance states the general rule for CE-marked goods: "a product subject to legislation referred to in paragraph 5 may be placed on the market only if there is an economic operator established in the Union who is responsible for the tasks set out in paragraph 3 in respect of that product" (Reg. 2019/1020 Art. 4(1)). That operator may be a Union manufacturer, an importer, a mandated authorised representative or a fulfilment service provider, and its Article 4(3) tasks are to verify the declaration of conformity and technical documentation exist, supply them on reasoned request, report risk, and cooperate on corrective action.

Medical devices, however, sit outside the closed list in Article 4(5), which names Regulations (EU) No 305/2011, (EU) 2016/425 and (EU) 2016/426 and a series of directives, but not Regulation (EU) 2017/745. Recital 4 explains why: on the lex specialis principle, "this Regulation should apply only in so far as there are no specific provisions with the same objective, nature or effect in Union harmonisation legislation" (Reg. 2019/1020, Recital 4), naming Regulation (EU) 2017/745 as an example. The effect is substitution, not a gap: MDR Article 11 does Article 4's work for devices, and does it more strictly, since a sole authorised representative is required rather than any one of four operator types.

Customs control: suspension and refusal of release for free circulation

Chapter VII of Regulation (EU) 2019/1020 does apply to devices. Article 2(2) provides that "Articles 25 to 28 shall apply to products covered by Union law in so far as there are no specific provisions relating to the organisation of controls on products entering the Union market in Union law." (Reg. 2019/1020 Art. 2(2)). The MDR contains no such customs machinery, so Articles 25 to 28 govern the frontier.

Under Article 25, Member States designate customs or market surveillance authorities to control products entering the Union market on a risk-analysis basis. Article 26(1) then requires them to suspend release for free circulation where, among other grounds, the product is not marked or labelled in accordance with the Union law applicable to it, or "for any other reason, when there is cause to believe that the product does not comply with the Union law applicable to it" (Reg. 2019/1020 Art. 26(1)(e)). A missing representative block on the label engages the labelling ground directly.

The clock then runs. Article 27 releases a suspended consignment where "within four working days of the suspension, the authorities designated under Article 25(1) have not been requested by the market surveillance authorities to maintain the suspension" (Reg. 2019/1020 Art. 27(a)). Where the surveillance authority concludes the product may not be placed on the market, Article 28(2) requires refusal of release and entry in the customs data-processing system of the notice "Product not in conformity — release for free circulation not authorised — Regulation (EU) 2019/1020" (Reg. 2019/1020 Art. 28(2)). For goods presenting a risk, Article 28(4) provides that designated authorities "may destroy or otherwise render inoperable a product which presents a risk to the health and safety of end users" (Reg. 2019/1020 Art. 28(4)), at the declarant's cost.

Inside the Union: the Article 94 to 97 procedure and Article 113 penalties

Stock already inside the Union is handled under the MDR itself. Article 94 requires competent authorities to evaluate a device where they have reason to believe it may present an unacceptable risk or "otherwise does not comply with the requirements laid down in this Regulation" (MDR Art. 94(b)). Absence of a designated representative falls into that second limb.

Where the evaluation finds non-compliance but no unacceptable risk, Article 97(1) requires the authority to make the operator "bring the non-compliance concerned to an end within a reasonable period that is clearly defined and communicated to the economic operator" (MDR Art. 97(1)). If that period passes, Article 97(2) obliges the Member State to "take all appropriate measures to restrict or prohibit the product being made available on the market or to ensure that it is recalled or withdrawn from the market" (MDR Art. 97(2)), and to notify the Commission and the other Member States through the Article 100 electronic system — which is how one national measure becomes a Union-wide problem. Where an unacceptable risk is present, Article 95 applies instead.

Financial consequences are not set at Union level. Article 113 provides that Member States lay down the rules on penalties for infringement of the Regulation and that "The penalties provided for shall be effective, proportionate, and dissuasive." (MDR Art. 113). Nothing further is harmonised: the ceiling, the procedure and whether liability is administrative or criminal are national questions, so the exposure of a manufacturer with no EU authorised representative depends on where the case arises.

Enforcement routes at a glance

Enforcement route	Who acts	What happens to the goods	Typical timing
Border suspension (Reg. 2019/1020 Arts. 25-26)	Customs or surveillance authority designated under Art. 25(1)	Release for free circulation suspended; surveillance authority notified	At declaration; lapses after four working days unless maintained (Art. 27(a))
Refusal of release (Reg. 2019/1020 Art. 28(2))	Market surveillance authority, via the designated authority	Not released; non-conformity notice entered in the customs system	On the finding of non-compliance; no fixed deadline
Destruction (Reg. 2019/1020 Art. 28(4))	Designated authority	Goods destroyed or disabled, at the declarant's cost	Where necessary and proportionate
Other non-compliance (MDR Art. 97)	National competent authority	Operator ordered to end it; failing that, restriction, prohibition, recall or withdrawal	A reasonable period set by the authority, then measures without delay
Unacceptable risk (MDR Art. 95)	Competent authority, then Commission and other Member States	Corrective action, restriction, withdrawal or recall, extended Union-wide	Period set by the authority; justified if unopposed within two months
Penalties (MDR Art. 113)	Member State under national law	Goods unaffected; sanction falls on the operator	National procedure; no Union tariff

The commercial consequences usually arrive first

The regulator is rarely the first obstacle. Article 13(2)(b) requires an importer, before placing a device on the market, to verify that "a manufacturer is identified and that an authorised representative in accordance with Article 11 has been designated by the manufacturer" (MDR Art. 13(2)(b)). An importer that takes its own obligations seriously refuses the shipment rather than inherit the non-compliance; if it has already taken delivery, it must not place the device on the market until the position is corrected. Our article on importer obligations under the MDR has the full checklist.

Registration is the second closed door. Article 31(1) requires that, "Before placing a device, other than a custom-made device, on the market, manufacturers, authorised representatives and importers shall, in order to register, submit to the electronic system referred to in Article 30 the information referred to in Section 1 of Part A of Annex VI" (MDR Art. 31(1)); the competent authority then issues the single registration number. In EUDAMED the actor registration of a manufacturer outside the Union is verified by its authorised representative, which must already be registered itself, before validation. A manufacturer with no EU authorised representatives on record cannot obtain an SRN, and without an SRN it cannot register devices or UDI data — see our guide to EUDAMED SRN registration.

Tendering closes third. Procurement dossiers routinely call for the EU declaration of conformity, the notified body certificate where one applies, labelling samples and the SRN of the registering operator. A bid from a manufacturer with no EU authorised representative fails on the documents alone, before price or clinical merit are reached: the label lacks a mandatory element and the registration number does not exist.

Where Medex fits

Medex Kurumsal Danışmanlık acts as EU authorised representative under MDR Article 11 and IVDR Article 11, registered in EUDAMED under SRN TR-AR-000057550, with offices in Ankara, İstanbul and Gdańsk, and an in-house person responsible for regulatory compliance with a deputy. We hold the mandate, carry the Article 11(3) tasks and run the EUDAMED registration chain; we do not perform notified body conformity assessment, write your technical documentation, or find distributors.