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United Kingdom Agency Issues Revised Guidance on Assistive Technologies

August 22, 2019

The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has revised its guidance on assistive technologies, products that support people with disabilities, restricted mobility or other impairments.

MHRA published guidance on the definition and safe use of assistive technologies this time last year. That document provided examples of assistive technologies that are classed as medical devices and gave an overview of the safety issues associated with the class of products. However, the document was light on information to help developers of assistive technologies determine whether a product would be classed as a medical device for regulatory purposes.

The revised guidance, which is significantly longer than its predecessor, is intended to address that shortcoming and other gaps in the earlier advice provided by MHRA. To help companies understand the regulatory status of their products, MHRA has added a definition of medical device and unpacked what it means for developers of assistive technologies.

MHRA decides the regulatory status of assistive products by looking for “a direct link between the corrective function of the equipment and the individual concerned.”

In explaining what that means in practice, MHRA cited the example of two wheelchairs. One is used by porters to transport anyone around a hospital. The second is a self-propelled wheelchair for people with disabilities. Only the second product is a medical device, as the other wheelchair lacks a clear link between the corrective function and the individual.

“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 wrote. The guidance discusses walking sticks and cushions to further articulate the difference.

MHRA Guidance

Source: Regulatory Affairs Professional Society