Control of Medical Device Marketing and Promotional Materials - EU regulation

J

Jnks_Meddev

#1
Does anyone know EU specific guidance or regulation specific to the control of marketing and promotional materials for medical devices?

Thanks!
 
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J

Jnks_Meddev

#3
Thank you Marcelo! Can you also share how to find this information or you know this based on your experience?
 

Al Rosen

Staff member
Super Moderator
#4
MDR said:
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.​
 

Al Rosen

Staff member
Super Moderator
#6

Mark Meer

Trusted Information Resource
#8
I've always been curious how this is handled/enforced when is comes to really vague/subjective language (e.g. "relaxation", "increase well-being",...), or claims that are not related to function (e.g. "top-of-the-line", "revolutionary technology",...).

As these examples are pretty innocuous, IMO, I don't see a big problem. ...but technically speaking, if you were claiming "revolutionary technology" when, in fact, your device is just another iteration of long-existing technology, then you'd technically be "ascribing...properties to the device which the device does not have", no?
 
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