Wellness product
Short definition
A wellness product is a product, device or app intended for leisure, relaxation or lifestyle, with no stated medical purpose, and which is therefore not regulated as a medical device.
In plain language
The boundary depends on the purpose the manufacturer assigns to it: a meditation app for everyday use is not a medical device, but a product presented as an aid in managing patients' pain acquires a medical purpose. For a healthcare institution, the distinction matters because only a medical device has undergone the conformity assessment, risk management and clinical evaluation required by Regulation (EU) 2017/745. If a product starts being presented with medical claims, it acquires a medical purpose and becomes subject to the MDR.
In practice, in an RVer session
The RVer base product is not a wellness product: it is a Class I medical device registered with Infarmed.