In brief
An electric scooter falls under the Medical Device Regulation only if the manufacturer intends it for a medical purpose covered by the Regulation, such as compensating for a disability, and completes the conformity assessment. Otherwise, it is an ordinary vehicle or consumer product.
Two similar products, two different regimes
Two scooters that look alike may be one a medical device and the other not: what decides it is the manufacturer's intended purpose, not appearance.
What changes for the buyer
For a medical device, the manufacturer must provide documentation, instructions and labelling that comply with the MDR. Its status may also be relevant for certain tax incentives, which should always be verified.
The SENIORBIKE case
SENIORBIKE's specific regulatory information is available on the page SENIORBIKE e certificazione MDR once confirmed by the manufacturer.
