MHRA Guidance Addresses Assistive Technology

To be considered a medical device, an assistive technology device must have a corrective function that directly links to a particular user’s needs, according to new guidance from the UK’s Medicines and Healthcare Products Regulatory Agency.

Assistive technology devices are intended to compensate for or alleviate an injury, handicap, or illness, or to replace a physical function. They can include mobility, communication, and hearing aids; posture and pressure management devices; moving and handling systems, such as hoists and slings; hospital beds; and therapy equipment.

Some assistive technology products like shower chairs are considered aids for daily living rather than medical devices because they do not directly compensate for a user’s injury or handicap, or because their primary purpose is for personal hygiene rather than to address a medical or mobility problem. — Jeff Kinney