What is the difference between an importer and a distributor under the MDR?

An importer places a device from a third country on the Union market for the first time and carries the obligations in Article 13, including adding its details to the EUDAMED registration. A distributor is defined in Article 2(34) as anyone in the supply chain other than the manufacturer or importer who makes a device available up to the point of putting into service, and carries the lighter Article 14 obligations. One company is frequently both, on different products.

Does translating instructions for use make a distributor a manufacturer?

No. Article 16(2)(a) MDR states that providing, including translating, the information supplied by the manufacturer under Section 23 of Annex I is not a modification that makes the distributor a manufacturer. But it does trigger Article 16(3) and 16(4): a quality management system, identification of the activity and the distributor on the device or its packaging, notification of the manufacturer and competent authority at least 28 days in advance, and a notified body certificate covering that quality management system.

Can a distributor rely on sampling for its Article 14 verifications?

Only partly. Article 14(2) allows a representative sampling method for the CE marking check, the information-supplied check and the UDI check — points (a), (b) and (d). It does not extend the sampling concession to point (c), the verification that an importer has complied with Article 13(3) for imported devices.

Is splitting a bulk carton into smaller quantities repackaging under Article 16?

No, provided the outer packaging of the device itself is not affected. MDCG 2021-26 confirms that splitting larger quantities, for example from a shipping container, into smaller quantities for onward supply is common wholesale practice and falls outside Article 16(2). The general Article 14 obligations still apply.

When does a private-label arrangement avoid Article 16(1)(a)?

Only when both conditions in the exception are met: the distributor or importer has an agreement with the manufacturer, the manufacturer is identified as such on the label, and the manufacturer remains responsible for meeting manufacturer obligations under the Regulation. If the label carries only the distributor's identity, the distributor assumes the obligations of a manufacturer regardless of what the contract says.

MDR Distributor Obligations and the Article 16 Trap

7 days ago

7 min read

The narrowest definition in the chain

Of the five economic operators the MDR recognises, the distributor is defined by subtraction. Article 2(34) provides that "‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service". You are a distributor because you are not one of the other things and you are supplying devices onward inside the Union.

That matters commercially, because the same company is frequently both. A Rotterdam wholesaler that brings devices in from a third country is an importer for those devices and a distributor for the ones it buys from a German manufacturer. The obligations attach per device, not per company. What an importer owes is a different list, dealt with separately in our post on importer obligations under the MDR; this article stays on the distributor side and on the boundary where a distributor stops being one.

Article 14(1): a standard of conduct, not a checklist

The article opens with an obligation that has no procedural content at all: "When making a device available on the market, distributors shall, in the context of their activities, act with due care in relation to the requirements applicable." Competent authorities use this sentence when nothing more specific fits. It is the reason a distributor cannot defend an unsafe supply by pointing out that Article 14(2) does not literally mention the failure in question.

The four verifications before making a device available

Article 14(2) requires a distributor to verify, before making a device available, that the device is CE marked and the EU declaration of conformity has been drawn up; that it is accompanied by the information the manufacturer must supply under Article 10(11); that for imported devices the importer has complied with Article 13(3), meaning the importer's name and contact address appear on the device, its packaging or an accompanying document; and that a UDI has been assigned where applicable.

The concession that follows is widely misread. For the CE marking, information and UDI checks — points (a), (b) and (d) — the distributor may apply a sampling method representative of the devices it supplies. Point (c), the importer identification check, is not in that list. Nothing in Article 14(2) permits sampling of importer particulars, and for a distributor handling third-country product that is the check most likely to fail.

Where a distributor considers or has reason to believe a device is non-conforming, it must not make it available until conformity is restored, and must inform the manufacturer, the authorised representative where applicable, and the importer. Where it believes the device presents a serious risk or is falsified, it must also inform the competent authority of its own Member State. Note the asymmetry: for ordinary non-conformity the notification runs up the supply chain, for serious risk it runs to the authority as well.

What continues after the sale

Article 14 does not end at the point of supply. While a device is under the distributor's responsibility, storage and transport conditions must comply with the conditions set by the manufacturer. Complaints and reports from healthcare professionals, patients or users about suspected incidents must be forwarded immediately to the manufacturer, the authorised representative where applicable, and the importer.

Article 14(5) also requires something concrete and auditable: a register of complaints, of non-conforming devices, and of recalls and withdrawals. This is the record inspectors ask for first, and it is the one most often reconstructed after the request rather than maintained before it. Article 25(2) sits behind it, requiring every economic operator to be able to identify to a competent authority who supplied them a device, who they supplied it to, and which health institutions or healthcare professionals received it directly.

Article 14(6) closes the loop on documentation. A distributor must provide a competent authority with all information and documentation at its disposal that is necessary to demonstrate a device's conformity — but is considered to have discharged that duty when the manufacturer or the authorised representative provides the required information instead. In practice this is one of the strongest arguments for a distributor to know exactly who the EU Authorised Representative for its portfolio is, and to have a working line to them before an authority calls.

Article 16(1): three ways to stop being a distributor

Article 16 is headed "Cases in which obligations of manufacturers apply to importers, distributors or other persons", and it means exactly what it says. A distributor assumes the full obligations of a manufacturer if it does any of three things.

Own-branding

The first is to make a device available "under its name, registered trade name or registered trade mark, except in cases where a distributor or importer enters into an agreement with a manufacturer whereby the manufacturer is identified as such on the label and is responsible for meeting the requirements placed on manufacturers in this Regulation". The exception is real, and it is narrow. Both conditions must hold: the manufacturer is identified as such on the label, and the agreement makes the manufacturer responsible for manufacturer obligations. A private-label deal that puts only the distributor's brand on the box does not qualify, whatever the contract says internally.

Changing the intended purpose

The second is to change the intended purpose of a device already placed on the market. Intended purpose is defined in Article 2(12) by reference to the manufacturer's label, instructions for use and promotional or sales materials. A distributor's own marketing claim can therefore change the intended purpose without a single physical change to the product — an entirely paper route to becoming a manufacturer.

Modifying the device

The third is to modify a device already placed on the market in such a way that compliance with the applicable requirements may be affected. Note "may be affected", not "is affected". The burden of showing that a modification is harmless sits with the person who made it.

Article 16(1) has one carve-out: it does not apply to a person who, while not a manufacturer as defined in Article 2(30), assembles or adapts a device already on the market for an individual patient without changing its intended purpose.

Article 16(2): the two activities that are not modifications

Relabelling and repackaging would obviously be modifications under Article 16(1)(c), so Article 16(2) carves them out. The first is "provision, including translation, of the information supplied by the manufacturer, in accordance with Section 23 of Annex I, relating to a device already placed on the market and of further information which is necessary in order to market the device in the relevant Member State". The second is changes to outer packaging, including a change of pack size, where the repackaging is necessary to market the device in that Member State and is carried out so the original condition of the device cannot be affected. For sterile devices, the Regulation presumes the original condition is adversely affected if packaging necessary to maintain sterility is opened, damaged or otherwise negatively affected.

"Necessary in order to market" is the operative test, and MDCG 2021-26 gives content to it: national language requirements, pack sizes suited to that Member State's health institutions, national practices permitting only certain packaging sizes, reimbursement rules tied to pack size, established prescription practices. Commercial preference is not necessity.

The same guidance draws two boundaries worth knowing. Splitting large quantities out of a shipping container into smaller sales quantities is not repackaging under Article 16(2), provided the device's outer packaging is untouched — ordinary wholesale practice stays ordinary wholesale practice. And a hospital breaking a bulk pack into units for internal circulation is not in Article 16 at all, because it is not marketing the device in a Member State.

What Article 16(3) and 16(4) then cost

Cross into Article 16(2) and two obligations arrive that most distributors are not built for.

Article 16(3) requires the activity performed, together with the distributor's name, registered trade name or trade mark, registered place of business and contact address, to be indicated on the device, its packaging or an accompanying document — a labelling change in its own right, on top of the requirements covered in our post on labelling under the MDR. It then requires a quality management system with procedures ensuring translations are accurate and up to date, that relabelling and repackaging preserve the original condition of the device, that repackaged packaging is not defective, poor quality or untidy, and that the distributor is informed of corrective actions the manufacturer takes.

Article 16(4) supplies the timing and the certificate. At least 28 days before making the relabelled or repackaged device available, the distributor must inform the manufacturer and the competent authority of the Member State concerned, and on request provide a sample or mock-up including any translated label and instructions for use. Within the same 28 days, "the distributor or importer shall submit to the competent authority a certificate, issued by a notified body designated for the type of devices that are subject to activities mentioned in points (a) and (b) of paragraph 2, attesting that the quality management system of the distributer or importer complies with the requirements laid down in paragraph 3". The misspelling of "distributer" is the Official Journal's own.

What the distributor does	Regulatory consequence
Ships CE-marked devices unaltered	Article 14 only
Splits a shipping container into smaller sales quantities, outer packaging untouched	Article 14 only — not Article 16(2)
Translates the IFU into a national language to market the device there	Article 16(2)(a): QMS under 16(3), notified body certificate and 28-day notice under 16(4)
Changes pack size because national reimbursement requires it	Article 16(2)(b): same obligations as above
Puts its own brand on the box with no compliant agreement	Article 16(1)(a): becomes the manufacturer
Advertises a use the manufacturer never intended	Article 16(1)(b): becomes the manufacturer

The distance between rows three and five of that table is the whole point. Translating an instruction leaflet is a regulated activity with a notified body attached. Printing your own logo on the carton is a change of legal identity. If you are unsure which side of Article 16 a planned commercial arrangement falls on, ask before the first consignment rather than after — talk to our regulatory team.