Intended purpose
Short definition
Intended purpose is the use for which the manufacturer intends the device, as stated on the label, in the instructions for use and in promotional or sales materials.
In plain language
The definition is in Article 2, point 12, of Regulation (EU) 2017/745. It is the intended purpose that determines whether a product is a medical device and which class it falls into. For this reason, what the manufacturer says about the product, including in advertising, must be consistent with what has been declared and assessed.
In practice, in an RVer session
RVer AI does not diagnose or prescribe; the RVer Motion, Neuro and Exposure modules are in development and outside the registration.