Is translating the instructions for use a modification under Article 16?

No. Article 16(2)(a) excludes the provision, including translation, of the information supplied by the manufacturer in accordance with Section 23 of Annex I, together with further information necessary to market the device in the relevant Member State. It is excluded from the modification limb only. The operator must still meet Article 16(3) and Article 16(4).

What does Article 16(4) require before a relabelled device goes on sale?

At least 28 days before making the relabelled or repackaged device available, the distributor or importer must inform the manufacturer and the competent authority of the Member State concerned, provide a sample or mock-up on request, and within the same 28 days submit to the competent authority a certificate issued by a notified body attesting that its quality management system complies with Article 16(3).

If Article 16 makes me the manufacturer, do I need an EU authorised representative?

Only if you are established outside the Union. Article 11(1) requires a sole authorised representative where the manufacturer of a device is not established in a Member State. A distributor inside the Union that becomes the manufacturer under Article 16 does not need one; a company outside the Union that puts its own brand on a device does.

MDR Article 16: When Relabelling, Repackaging or Own-Brand Labelling Makes You the Manufacturer

Q: Does selling a device under my own brand make me the manufacturer under MDR?

Usually yes. Article 16(1)(a) provides that a distributor, importer or other person assumes the obligations incumbent on manufacturers if it makes available on the market a device under its name, registered trade name or registered trade mark. There is one carve-out: where the distributor or importer enters into an agreement with the manufacturer whereby the manufacturer is identified as such on the label and remains responsible for the manufacturer requirements. Without that agreement and without the real manufacturer on the label, the own-brand labeller is the manufacturer for MDR purposes.

Q: Can repackaging break the Article 16(2) carve-out?

Yes, for sterile devices. Article 16(2)(b) states that in the case of devices placed on the market in sterile condition it shall be presumed that the original condition of the device is adversely affected if the packaging necessary for maintaining the sterile condition is opened, damaged or otherwise negatively affected by the repackaging.

6 days ago

8 min read

Article 16 of MDR 2017/745 answers a question that decides an entire regulatory file: when a device passes through more than one company on its way to the patient, which of them is the manufacturer? The answer is not settled by who made the product. It is settled by whose name is on the label, whether the intended purpose has changed, and whether the device itself has been altered.

The article matters commercially because the three limbs of paragraph 1 are easy to trip over without noticing. A Turkish exporter that buys finished goods in Asia and sells them in Europe under its own trade mark is a manufacturer under MDR, not a distributor. A European importer that translates an instruction leaflet is not — provided it does several other things. This guide takes the article limb by limb and then sets out what each answer means for the EU authorised representative appointment.

The three activities that transfer manufacturer obligations

The operative rule is in the opening of paragraph 1: "A distributor, importer or other natural or legal person shall assume the obligations incumbent on manufacturers if it does any of the following: (a) makes available on the market a device 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; (b) changes the intended purpose of a device already placed on the market or put into service; (c) modifies a device already placed on the market or put into service in such a way that compliance with the applicable requirements may be affected." (MDR Article 16(1))

Three points deserve attention. The subject is not limited to distributors and importers — it extends to any other natural or legal person, which captures group companies, agents and service providers who would not describe themselves as economic operators at all. The consequence is not partial: the person assumes the obligations incumbent on manufacturers, meaning the whole of Article 10, from technical documentation to post-market surveillance. And the three limbs are alternatives; one is enough.

Paragraph 1 closes with a narrow exclusion: "The first subparagraph shall not apply to any person who, while not considered a manufacturer as defined in point (30) of Article 2, assembles or adapts for an individual patient a device already on the market without changing its intended purpose." (MDR Article 16(1)) This is the orthopaedic workshop and the optician. It preserves patient-level adaptation without turning every fitting into an act of manufacture. It does not cover batch adaptation, and it does not cover anyone who already meets the Article 2(30) definition of manufacturer.

Own-brand labelling: the exception that has to be earned

Point (a) is the limb that catches most companies. Putting your name, trade name or trade mark on a device you did not design makes you its manufacturer under MDR unless a specific arrangement is in place. The exception has two cumulative conditions written into the text: there must be an agreement with the manufacturer, and under that agreement the manufacturer must be identified as such on the label and remain responsible for meeting the manufacturer requirements.

A private-label contract that is silent on the label is not enough. If the box carries only the reseller's name, the reseller is the manufacturer whatever the contract says between the parties, because the exception is drafted around what appears on the label rather than around the commercial arrangement. Section 23.2(a) of Annex I requires the label to bear the manufacturer's name or trade name and registered place of business, and Article 16(1)(a) simply reads onto that requirement.

The consequence is the full Article 10 set: technical documentation to Annexes II and III, a EU declaration of conformity, a Basic UDI-DI, a person responsible for regulatory compliance, a post-market surveillance system, and — where the own-brand company sits outside the Union — an authorised representative under Article 11. Our overview of the underlying regime is in MDR Article 11.

The two activities that are not modifications

Paragraph 2 removes two common commercial acts from the reach of point (c). The first is language work: "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" (MDR Article 16(2)(a)).

The second is outer packaging: "changes to the outer packaging of a device already placed on the market, including a change of pack size, if the repackaging is necessary in order to market the device in the relevant Member State and if it is carried out in such conditions that the original condition of the device cannot be affected by it. In the case of devices placed on the market in sterile condition, it shall be presumed that the original condition of the device is adversely affected if the packaging that is necessary for maintaining the sterile condition is opened, damaged or otherwise negatively affected by the repackaging." (MDR Article 16(2)(b))

The sterile presumption is the sharp edge. For a sterile surgical glove or a sterile instrument, opening the sterile barrier to rebox the product is presumed to affect the original condition, which pulls the operator back under point (c) and therefore back under Article 10. Repackaging that leaves the sterile barrier untouched — placing sealed pouches into a different carton — stays inside the carve-out.

Note also what paragraph 2 does not do. It does not exempt anyone from point (a) or point (b). A distributor that translates a leaflet and puts its own brand on the box is still a manufacturer, because the brand limb is untouched by the carve-out.

Article 16(3): identification and a quality management system

An operator relying on the carve-out is not left unregulated. Paragraph 3 imposes two duties. First, identification: "A distributor or importer that carries out any of the activities mentioned in points (a) and (b) of paragraph 2 shall indicate on the device or, where that is impracticable, on its packaging or in a document accompanying the device, the activity carried out together with its name, registered trade name or registered trade mark, registered place of business and the address at which it can be contacted, so that its location can be established." (MDR Article 16(3))

Second, a quality management system: "Distributors and importers shall ensure that they have in place a quality management system that includes procedures which ensure that the translation of information is accurate and up-to-date, and that the activities mentioned in points (a) and (b) of paragraph 2 are performed by a means and under conditions that preserve the original condition of the device and that the packaging of the repackaged device is not defective, of poor quality or untidy." (MDR Article 16(3)) The same paragraph requires that system to cover procedures ensuring the operator is informed of any corrective action taken by the manufacturer.

The phrase not defective, of poor quality or untidy is unusual drafting for a regulation and is worth taking literally: the appearance of the repackaged unit is a compliance parameter, not a commercial preference.

Article 16(4): 28 days, a sample and a notified body certificate

The procedural obligation is the one most often discovered late. "At least 28 days prior to making the relabelled or repackaged device available on the market, distributors or importers carrying out any of the activities mentioned in points (a) and (b) of paragraph 2 shall inform the manufacturer and the competent authority of the Member State in which they plan to make the device available of the intention to make the relabelled or repackaged device available and, upon request, shall provide the manufacturer and the competent authority with a sample or mock-up of the relabelled or repackaged device, including any translated label and instructions for use. Within the same period of 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." (MDR Article 16(4))

A notified body certificate is required even where the device itself is class I and needed no notified body at all. The certificate is about the operator's quality management system, not about the product. Companies that plan a European roll-out around translation and repackaging should budget for that assessment and for the 28-day clock in each Member State where they intend to make the device available. The role of notified bodies more generally is covered in notified bodies under MDR.

Where the authorised representative fits

Article 16 changes who the manufacturer is. Article 11 then decides whether that manufacturer needs a representative: "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)) Two situations follow.

If a company established inside the Union becomes the manufacturer under Article 16 — a German distributor selling under its own brand, for example — no authorised representative is required. That company is an EU manufacturer with the full Article 10 burden and no Article 11 appointment to make.

If a company established outside the Union becomes the manufacturer, an authorised representative is mandatory before the first unit is placed on the market. This is the position of exporters who source finished product abroad and sell it in Europe under their own mark. They are not distributors in the MDR sense and cannot rely on distributor obligations; they carry Article 10 and they need an Article 11 mandate.

One more consequence deserves emphasis. Under Article 11(5), where the manufacturer is not established in a Member State and has not complied with Article 10, "the authorised representative shall be legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer." (MDR Article 11(5)) An own-brand labeller with a thin technical file is therefore a difficult client for any representative, which is why serious providers review the documentation before signing rather than after. The scope of that liability is set out in authorised representative liability.

A short decision sequence

Four questions settle most files. Whose name is on the label — and if it is yours, is the actual manufacturer also named there under a written agreement? Has the intended purpose changed in any marketing claim, instruction or indication? Has the device been altered in any way that could affect compliance, including opening a sterile barrier? And if the answer to any of those puts you in the manufacturer's chair, are you established inside the Union or outside it?

Answering those questions honestly at the contract stage is far cheaper than answering them in response to a competent authority request.

Medex Kurumsal as your EU authorised representative

If you place devices on the European market under your own brand from outside the Union, Article 11 of MDR 2017/745 — and Article 11 of IVDR 2017/746 for in vitro diagnostics — requires a single authorised representative established in a Member State before those devices reach the market. Medex Kurumsal Danismanlik acts as EU authorised representative under both Regulations, registered in EUDAMED under SRN TR-AR-000057550.

What the mandate covers: verification of the EU declaration of conformity and the technical documentation before signature rather than after; the Article 11(3)(a) copy of the file kept available for the full retention period; EUDAMED actor and device registration and the Basic UDI-DI submission; the registered EU address printed on your label and instructions for use; handling of competent authority requests, samples and information in the language of the Member State concerned; and the vigilance interface under Articles 87 to 90.

We read the file before accepting a mandate, because Article 11(5) makes the authorised representative jointly and severally liable for defective devices where the manufacturer has not complied with Article 10. A file we have not read is a liability we cannot price. Our fee structure is published on the EU authorised representative cost page, and the scope of the service is set out under EU authorised representative. Send us the declaration of conformity and the device list and we will tell you within two working days whether the file is ready for a mandate and what is missing if it is not.