Prior to the innovations introduced by Article 7 of the Medical Device Directive 2017/745 (the “MDR”) there was little uniformity of approach or guidance on the issue of advertising and what statements could be made in relation to medical devices (“Advertising).
There was no reference to Advertising in the Medical Device Directive 93/42/EEC of 14 June 1993 (the “MDD”). However, in implementing the MDD, Italy (in art 21 of its Legislative Decree 46/97, the “Decree”) introduced rules and regulations on Advertising which are still applicable today.
In particular the Decree:
- Prohibited Advertising to the public of (i) customized medical devices, and (ii) medical devices requiring a doctor’s prescription or assistance of a doctor or other healthcare professional;
- Required authorisation from the Ministry of Health for any medical device not falling within paragraph A above (“Authorisation”), and publication of the Authorisation in/on any Advertising; and
- Provided for an exemption from Authorisation for (i) Advertising aimed exclusively at (and accessible by) healthcare professionals, (ii) so-called “institutionaladvertising” ie, all forms of communication aimed at promoting the name, brand or image of a company as opposed to a particular device. However, if the Advertising were to boast specific properties of the medical device referred to, it would be classified as “commercial” advertising and be subject to the art 21 of the Decree.
Advertising in the European Union following the MDR
The novelties of Article 7 of the MDR close many of the gaps in Advertising, providing a more detailed roadmap towards improved patient safety through increased responsibility and accountability on the part of manufacturers of devices made available in the European Union. In particular, Article 7 (i) applies to labels, instructions for use, making available, putting into service and advertising of devices, and (ii) prohibits misleading the user or patient (by using “text, names, trademarks, pictures and figurative or other signs”) as to a device’s intended purpose, safety and performance. Specifically, Advertising must not:
(a) ascribe functions and properties to the device which the device does not have;
(b) create a false impression regarding treatment or diagnosis, functions or properties which the device does not have;
(c) fail 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) suggest uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.”
Advertising must therefore be supported by the clinical evaluation which must in turn be corroborated by clinical data.