Does an online shop outside the EU selling medical devices to EU consumers have to comply with the MDR?

Yes. Article 6(1) MDR provides that a device offered by means of information society services to a natural or legal person established in the Union shall comply with the Regulation. The trigger is the offer to a person in the Union, not the location of the seller or the origin of the shipment. There is no exemption for small order volumes or for parcels described as personal imports.

What is an information society service for the purposes of MDR Article 6?

It is defined by reference to Directive (EU) 2015/1535: any service normally provided for remuneration, at a distance, by electronic means and at the individual request of a recipient of services. Services provided in the physical presence of provider and recipient are excluded, including a medical examination at a doctor's surgery using electronic equipment where the patient is present.

Does MDR Article 6 apply if the device is never sold, only used to provide a service?

Yes. Article 6(2) covers a device that is not placed on the market but is used in the context of a commercial activity, for payment or free of charge, to provide a diagnostic or therapeutic service offered by information society services or by other means of communication, directly or through intermediaries, to a person established in the Union. Remote laboratory analysis and remote scan reading for EU patients are typical examples.

Does distance selling into the EU require an EU Authorised Representative?

Yes, where the manufacturer is not established in a Member State. Article 11(1) allows a device to be placed on the Union market only if the manufacturer designates a sole authorised representative. Article 6 does not create an exception to that, and the sales channel does not change the obligation.

What can a competent authority ask an online seller for under Article 6(3)?

A copy of the EU declaration of conformity for the device concerned. Article 6(3) applies both to a person offering a device under Article 6(1) and to a person providing a service under Article 6(2), and the request can be made by any competent authority.

Can a Member State shut down an online service selling non-compliant devices?

Yes. Article 6(4) allows a Member State, on grounds of protection of public health, to require a provider of information society services to cease its activity. The measure targets the service provider rather than a specific consignment of goods.

Selling Medical Devices Online Into the EU: MDR Article 6

Sep 6

6 min read

One short article, two very different limbs

Article 6 of Regulation (EU) 2017/745 is four paragraphs long and is routinely read as "online sales are covered too". It is doing more than that. Its first limb captures devices sold at a distance. Its second captures devices that are never sold at all, but are used to deliver a service to someone in the Union. The two limbs catch different business models, and the second one catches models that were designed specifically to avoid the first.

Recital 21 sets out the intention: it should be made clear that it is essential that devices offered to persons in the Union by means of information society services, and devices used in the context of a commercial activity to provide a diagnostic or therapeutic service to persons within the Union, comply with the requirements of the Regulation, where the product is placed on the market or the service is provided in the Union.

What counts as an information society service

Article 6 borrows its definition from point (b) of Article 1(1) of Directive (EU) 2015/1535, where "‘service’ means any Information Society service, that is to say, any service normally provided for remuneration, at a distance, by electronic means and at the individual request of a recipient of services." The Directive then defines "‘at a distance’ means that the service is provided without the parties being simultaneously present".

Three elements have to be present together: remuneration, distance, electronic means, at individual request. A webshop, a marketplace listing, an app-based ordering flow and an automated online consultation all qualify. The Directive's own indicative list excludes services provided in the physical presence of provider and recipient, including a medical examination or treatment at a doctor's surgery using electronic equipment where the patient is physically present. A telemedicine platform is inside Article 6; the same clinician using the same device in the room with the patient is not.

The first limb: a device offered online to a person in the Union

The rule itself is one sentence: "A device offered by means of information society services, as defined in point (b) of Article 1(1) of Directive (EU) 2015/1535, to a natural or legal person established in the Union shall comply with this Regulation."

The trigger is the offer, not the shipment, and not the seller's location. A site in any country that offers a device to a person established in the Union brings that device inside the MDR. There is no de minimis for order volume, no exemption for "personal import", and no relief because the goods ship from outside the EU.

Read this together with Article 2(28), where "‘making available on the market’ means any supply of a device, other than an investigational device, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge". Free samples, influencer gifting programmes and promotional units are supply. The absence of a payment removes nothing.

The second limb: the service that never sells a device

Article 6(2) is the paragraph that surprises people, and it is worth quoting in full: "Without prejudice to national law regarding the exercise of the medical profession, a device that is not placed on the market but used in the context of a commercial activity, whether in return for payment or free of charge, for the provision of a diagnostic or therapeutic service offered by means of information society services as defined in point (b) of Article 1(1) of Directive (EU) 2015/1535 or by other means of communication, directly or through intermediaries, to a natural or legal person established in the Union shall comply with this Regulation."

Take that apart. The device is not placed on the market — it stays with the provider. It is used commercially, paid or unpaid. It delivers a diagnostic or therapeutic service. The service is offered by electronic means or by other means of communication, directly or through intermediaries, to someone in the Union. That device must comply with the MDR.

So a laboratory outside the Union that analyses samples sent by EU consumers, a remote-reading service interpreting scans for EU patients, an online symptom-assessment tool that produces a diagnostic output, and a platform that arranges any of these through a local intermediary are all inside Article 6(2). No product ever crosses the border, and the Regulation applies anyway. The phrase "or by other means of communication" also means the second limb is not confined to the internet.

Why the economic-operator chain does not disappear

Article 6 sets a compliance requirement; it does not create a special regime. Once a device must comply with the Regulation, the whole structure applies: Annex I general safety and performance requirements, conformity assessment, the EU declaration of conformity, CE marking, UDI, registration, post-market surveillance and vigilance.

The pivot is Article 11(1): "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." The obligation attaches to the manufacturer, not to the sales channel, and no webshop architecture removes it.

Two consequences follow that direct-to-consumer sellers regularly miss. First, somebody is the importer. If a third-country manufacturer ships fulfilment stock into a Union warehouse, whoever places that stock on the Union market is an importer under Article 2(33) and owes the Article 13 duties, including adding their details to the registration under Article 31. Second, Article 10(11) requires the information in Section 23 of Annex I to be supplied in an official Union language determined by the Member State where the device is made available to the user or patient. A single English-language listing serving twenty-seven markets does not satisfy it.

Four selling models, and where each one lands

Model	Article 6 limb	Who is the importer	What the third-country manufacturer needs
Manufacturer's own webshop, parcels posted from outside the EU to EU consumers	6(1)	No EU importer if the manufacturer supplies direct; the manufacturer places the device on the Union market	CE marking, EU Authorised Representative, EUDAMED registration, EU-language information
Manufacturer's stock held in an EU fulfilment centre, sold online	6(1)	The entity that places the stock on the Union market	All of the above, plus an identified importer meeting Article 13
Marketplace listing operated by an EU seller sourcing from a third country	6(1)	The EU seller	All of the above; the EU seller is importer and, on resale, distributor
Remote diagnostic or therapeutic service using a device never supplied to the user	6(2)	None — nothing is placed on the market	The device must still comply with the MDR; the service provider must produce the declaration of conformity on request

Article 6(3) and 6(4): how the article is enforced

The declaration of conformity, on demand

The enforcement handle is deliberately simple: "Upon request by a competent authority, any natural or legal person offering a device in accordance with paragraph 1 or providing a service in accordance with paragraph 2 shall make available a copy of the EU declaration of conformity of the device concerned."

This is the cheapest market surveillance mechanism in the Regulation. An authority does not need to intercept a shipment or commission testing; it sends an email to the seller or the service provider and asks for the EU declaration of conformity. Silence, or a document that is not a declaration of conformity, is itself the finding. Anyone selling online into the Union should be able to answer that request in a day, in the name of the legal entity making the offer.

The power to switch a service off

The last paragraph is short and unusual: "A Member State may, on grounds of protection of public health, require a provider of information society services, as defined in point (b) of Article 1(1) of Directive (EU) 2015/1535, to cease its activity." The measure is aimed at the service provider — a platform, a host, a seller — rather than at a consignment of goods, and it can be exercised on public health grounds without a product recall. For an online business, that is a materially different exposure from a customs stop.

What a third-country manufacturer selling direct to EU consumers actually needs

A device that is compliant on its own terms: conformity assessment completed, CE marking applied, EU declaration of conformity issued and current.
A designated sole EU Authorised Representative under Article 11, with a written mandate covering the devices offered, effective at least for all devices of the same generic device group.
Registration in EUDAMED and an SRN, plus UDI assignment and the device registration under Article 29.
Label and instructions for use in the official language or languages of every Member State the site actually sells into, not only the language the site is written in.
A clear answer to who the importer is for any stock held inside the Union, with that operator's details on the device, packaging or accompanying document and added to the registration.
A post-market surveillance and vigilance route that works for consumer complaints arriving by email and web form, not only for clinical incident reports from hospitals.

Medex acts as EU Authorised Representative under EUDAMED SRN TR-AR-000057550 and handles the associated registration work; we do not perform conformity assessment and we do not find distributors. If you sell online into the Union and are unsure which of the six points above is missing, start with the EU Authorised Representative service and the EUDAMED registration page, or look at published annual fees by class on pricing.