2017/745_AnnexI  _ II_III_ IV_ V_ VI_ VII_ VIII_IX_X_XI_XII_XIII_XIV_XV_XVI_XVII

Article 6
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.

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.

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.

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.

Article 7
Claims

In the labelling, instructions for use, making available, putting into service and advertising of devices, it shall be prohibited to use text, names, trademarks, pictures and figurative or other signs that may mislead the user or the patient with regard to the device's intended purpose, safety and performance by:

(a)

ascribing functions and properties to the device which the device does not have;

(b)

creating a false impression regarding treatment or diagnosis, functions or properties which the device does not have;

(c)

failing to inform the user or the patient of a likely risk associated with the use of the device in line with its intended purpose;

(d)

suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.