The Medical Devices Regulation (MDR) sets the requirements for medical devices and devices without an intended medical purpose and that can have an aesthetic function. Specifically, Annex XVI of the MDR lists such devices.
Some examples of such devices are contact lenses (including coloured contact lenses), tattoo or hair removal devices, dermal fillers, body sculpting equipment, solid body contour modifying implants
According to the MDR, the common specifications products listed in Annex XVI must address, at least, application of risk management and, where necessary, clinical evaluation regarding the safety of the product.