MDR - Chapter I - article 6
Original text
Expert opinion
Distance sales
1. 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.
Distance sales
1. Distance sales in this paragraph is understood as sales conducted via eShops or alike. This paragraph understands, that eShops selling medical devices as defined in the MDR must comply with the MDR.
2. 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.
2. Direct and indirect eShops of the legal manufacturer must comply with the MDR. Further, eShops of distributors or any other economic operator must comply with the MDR.
3. 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.
3. eShops offering medical devices must have access to the EU declaration of conformity (DoC) provided by the legal manufacturer. “To make available” in this paragraph means that there must be access to the DoC upon request by authorites and not necessarily, that the DoC is available in print or other at the eShop’s premisses.
4. 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.
4. In situations, at which the public health has to be protected, the authority has the right to cease the eShop’s operations. Such cases can be when a medical device is made available without CE-mark, other ways of illegal marketing or in cases of recalls and field actions.
