Online distribution of medical devices is expressly addressed in Article 6 of the MDR, which states that a medical device which is “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” must comply with the requirements of the MDR. Article 1(1)(b) defines an information society service as “any service normally provided for remuneration, at a distance, by electronic means and at the individual request of a recipient of services.”
First, providers of these devices are subject to the requirements for distributors in accordance with Article 14 of the MDR.
The general duties for distributors of medical devices are defined in Article 14 of the MDR.
Accordingly, distributors are required to verify that:
- the device has CE marking and that an EU Declaration of Conformity has been drawn up;
- the information which is to be supplied by the manufacturer has been included;
- an UDI has already been assigned by the manufacturer, if applicable.
Since a copy of the EU Declaration of Conformity for the offered device must be made available at the request of a competent authority in accordance with Article 6(3) of the MDR, it would be advisable to obtain a copy of this declaration from each manufacturer before including devices in the online platform.
If a distributor is of the opinion or has reason to believe that a device fails to meet the MDR’s requirements, it may not supply the relevant device until its conformity has been established. In such a case, the distributor is required to notify the manufacturer or the manufacturer’s authorized representative. This notification requirement also applies in case of potentially non-conforming devices which have already been placed on the market, and distributors are also required to cooperate with the competent supervisory authorities if necessary.
Distributors are also required to verify that the information which is to be supplied by the manufacturer in accordance with Article 10(11) of the MDR has been included with the device. The reference is to the information required in Annex I Chapter III Section 23 of the MDR, in the form of labeling and instructions for use.
The labels for offered devices must contain the following information:
- the name or trade name of the device;
- the intended purpose of the device;
- the name and registered trade name/registered trademark of the manufacturer;
- the manufacturer’s address;
- the name and address of the manufacturer’s authorized representative, if the manufacturer is not based in Europe;
- information about certain product components and/or hazardous materials (e.g. medicinal substances, human or animal blood/plasma tissues/cells, carcinogenic materials, nanomaterials, etc.);
- the device’s lot number/serial number;
- the UDI carrier, if applicable;
- information about the time limit for use of the device or the date of manufacture;
- information about any storage or handling conditions;
- reference to sterility and sterilization methods;
- any warnings or precautions to be taken; and
- an indication if the device is intended for single use.
In accordance with Article 7 of the MDR, those supplying and advertising medical devices are prohibited from using text, names, trademarks, pictures and figurative or other signs which could mislead users or patients with regard to the device’s intended purpose, safety and performance.
In particular, they may not:
- ascribe functions and properties to the device which it does not possess;
- create a false impression regarding treatment or diagnosis, functions or properties which the device does not possess;
- fail to inform the user of the expected risks associated with use of the device in line with its intended purpose;
- recommend uses for the device other than those which are identified as part of the intended purpose for which the conformity assessment was performed.
In addition, a CE marking is a prerequisite for placement of medical devices on the market. The CE marking indicates that the device conforms to the legal requirements applicable to the device in accordance with European rules. Accordingly, a CE marking is a “must have” for distribution of the device, and is not just a particular kind of quality seal. As a result, distributors may not advertise devices on their online platforms using terms like “CE-tested’ or “CE-certified”: these terms qualify as misleading advertising in terms of the Act Against Unfair Competition [Gesetz gegen den unlauteren Wettbewerb] (only in German). With regard to the term “CE-certified,” the fact is that a declaration of conformity with an EU Directive (in the future, the MDR) is not the same as certification and award of a CE marking by an independent body.
Summary and recommendation
Even devices which are distributed via an online platform are required to meet the MDR’s requirements. The CE marking must be affixed to the device or its packaging in a clearly visible, legible and indelible manner. The device’s labeling must be complete.
Suppliers of medical devices are subject to the requirements for distributors in accordance with Article 14 of the MDR.
Distributors should not modify the manufacturer’s statements and product information in any way. If they do so, there is a risk that the manufacturer’s duties and liability risks may be transferred to the online distributor. If the platform is accessible to consumers, special requirements apply for advertising statements. Violations of these requirements will be particularly interesting to competitors, who will eagerly use them as the basis for cease and desist letters and desistance actions.back