Regulation (EU) 2017/745 of the European Parliament and of the CouncilShow full title

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance)

Article 7U.K.Claims

[X1In the labelling, instructions for use, making available, putting into service and advertising of devices, it shall be prohibited to use text, names, trade marks, 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.

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