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:
ascribing functions and properties to the device which the device does not have;
creating a false impression regarding treatment or diagnosis, functions or properties which the device does not have;
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;
suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out
Powered by TS Q&E - ISO 13485:2016 Medical Device Consulting Services
Manage Cookie Consent
The technical storage or access is strictly necessary for the legitimate purpose of enabling the use of a specific service explicitly requested by the subscriber or user, or for the sole purpose of carrying out the transmission of a communication over an electronic communications network.
The technical storage or access is necessary for the legitimate purpose of storing preferences that are not requested by the subscriber or user.
The technical storage or access that is used exclusively for statistical purposes.The technical storage or access that is used exclusively for anonymous statistical purposes. Without a subpoena, voluntary compliance on the part of your Internet Service Provider, or additional records from a third party, information stored or retrieved for this purpose alone cannot usually be used to identify you.
The technical storage or access is required to create user profiles to send advertising, or to track the user on a website or across several websites for similar marketing purposes.