MDR - Chapter II - article 7
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.
In any communication, whether it is in the instructions for use (IFU), on the label, on a website or any other marketing documentation, the made claims must be based on the intended use and primary mode of action of the medical device.
a + b) the functions and properties claimed in any documentation of the product must be supported by data. It is not unusal to verify properties and validate the use or a function.
c) the IFU must bear warning and risks to the patient in the cases the products has such risks. Sometimes, these risks are described in side-effects or contra-indications.
d) it is forbidden to use a medical device outside the indicated use, referred to as off-label use.
Claim management provides a drop-down approach to claims control and can be used during technical and usability development.
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