MHRA Guidance on Assistive Technology: medical device or not?

Products that assist and support individuals with disabilities, restricted mobility or other conditions to perform functions that would be difficult to perform without such products are known as ‘Assistive Technology’.

Classifying these products is not an easy task as they might be a medical device or an ‘aid for daily living’.

The UK Competent Authority MHRAhas published a guidance to clarify how these products should be classified, noting that it will likely be classified as a medical device, if there is a direct link between the corrective function of the equipment and the individual concerned.

It is crucial for the MHRA that the manufacturer specifies whether a device is intended to be used by specific individuals for a stated medical purpose; on the contrary, it is unlikely that the product will be classified as a medical device. Therefore, the classification depends on the claims made by the manufacturer for each product.

The MHRA also presents few examples, such as

‘’ Cushions which are intended to relieve pressure and prevent pressure sores for use by wheelchair users who spend long hours sitting in the chair would likely be considered to be medical devices because they have a clear medical purpose and a clear link between the corrective function (to relieve pressure and prevent pressure sores) and the individual (wheelchair user).

However, ordinary cushions (including those used in hospital or healthcare environments) would not be considered medical devices because their primary purpose is for comfort rather than medical and they can be used by anyone.’’

Additionally, the MHRA states that these classifications should be assessed on a case-by-case scenario, as each member state may have a different approach. Read the whole guidance here.

Clàudia Miralles

Regulatory Affairs Department

October 1st, 2019

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