Chapter 2 (Art 5 - 24) – Making available on the market and putting into service of devices, obligations of economic operators, reprocessing, CE marking, free movement
Article 6 – Distance sales
A device offered by means of information society services, as defined in point (b) of Article 1(1) of
, to a natural or legal person established in the Union shall comply with this Regulation.
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
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.
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.
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
