The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has revised its guidelines on assistive technologies and products which are designed to support disabled people with restricted mobility and with other impairments.
Last year, the MHRA had presented a definition of the safe use of assistive technologies. However, the guidance lacked information which could help developers with assistive technologies to determine if a product could be classified as a regulatory purpose or a medical device.
The revised guidance is thus longer in comparison and centers on the shortcomings of the previous advice provided by MHRA. In order to help companies comprehend the regulatory status of their products, MHRA has supplemented a definition of the medical device, in addition to an explanation of what it could mean to developers of assistive technologies.
MHRA helps in deciding the regulatory status of assistive products by means of “a direct link between the corrective function of the equipment and the individual concerned.”
MHRA explains this with the help of an example of two wheelchairs. One of the chairs is used by porters to transport people around the hospital, the other is a self-propelled wheelchair designed for people with disabilities. MHRA explains that the second is a medical device, whereas the first one lacks a link between the individual and the corrective function.
“Unless a manufacturer specifies that a product is intended to be used by individuals for a stated medical purpose, the product could be used by anyone, regardless of whether they have a medical condition. If a product can be used by anyone then it is unlikely to be a medical device,” MHRA observes.