5. How to determine if a product is a medical device

Last Updated on 06/11/2025 by Sarah Sarsby

To determine if a product is a medical device and, if so, into which class it fits (as per Section 2), the following sources of information can be used.

MHRA Guidance:

• Borderline products: classifying medical devices and risk

This provides a comprehensive overview of how MHRA makes decision on whether a product is a medical device and which risk class should apply. It also includes information on how to get advice about your product from the MHRA and provides links to other borderline guidance.

• Borderline products: medical devices and medicinal products
• MHRA – Borderlines with Medical Devices and Other Products

MHRA guidance to assist in determining whether a product falls within the definition of a medical device for the purposes of UK legislation/regulation. See especially, Section 5 – Assistive technology products (aids for daily living):

Equipment intended for alleviation of, or compensation for a disability may or may not be considered medical devices. The determining factor will be whether or not there is a direct link between the corrective function of the equipment and the individual concerned and whether there is a stated medical purpose. The following products are considered to be medical devices as there is such a direct link:

• Baths with integral hoists
• External limb prostheses and accessories
• Hearing aids
• Mobility aids for the visually impaired
• Orthopaedic footwear
• Orthoses (lower/upper limb, spinal, abdominal, neck, head)
• Patient hoists
• Rehabilitation tricycles / mobility carts
• Walking / standing frames
• Walking sticks / crutches
• Wheelchairs

Other products, however, will be considered as ‘general equipment’ since it may be used ‘by all’ (rather than having a direct link with the individual concerned). Such products are usually considered as ‘aids for daily living’ and are not medical devices, for example:

• Acoustic signals at traffic lights
• Baths with doors
• Grab rails (at doorways, stairs etc.)
• Personal alarm systems / home alarm systems
• Portable ramps
• Special water taps
• Stair lifts
• Toilet equipment for the disabled / elderly (e.g. toilet seats, shower seats, commodes)

• Assistive Technology – Definition and Safe Use

MHRA further defines what it considers a medical device in the context of assistive technologies. In addition to the examples in the borderlines guidance above, see especially its definitions of:

Assistive technology products that are medical devices:

• Communication aids
• Epilepsy / enuresis monitors
• Pressure management devices (pressure redistribution/relief cushions and mattresses)
• Posture management devices (from simple cushions to complex support systems)
• Slider boards
• Standing aids
• Sport-model wheelchairs

Aids to daily living products that are not medical devices:

• Bariatric chairs and stools
• Chair risers
• Fall alarms
• Wheelchair vehicle restraints
• Rise-and-recline chairs
• Shower chairs

• Borderline and Classification Issues for IVDs – EU Guidance Document

To determine if a product is an IVD and, if so, into which class it fits.

If, after reviewing the guidance above, clarification is still required as to whether a product is a medical device, or into which risk class a medical device falls, you may email devices.borderlines@mhra.gov.uk including full details of the product, its intended purpose and how it works.

EU Guidance:

• MDCG 2022 – 5 Rev. 1 – Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices

Explains borderline products, drug-delivery products and medical devices incorporating, as integral part, an ancillary medicinal substance or an ancillary human blood derivative. Clarifies when something is a medical device vs a medicinal product under the new MDR (2017/745).

• MDCG 2021-24 – Guidance on classification of medical devices

Covers risk classification of medical devices.

• Manual on borderline and classification for medical devices under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices

Represents the agreements reached by the EU competent authorities (Borderline & Classification Working Group) under the MDCG, useful reference to previous borderline decisions.

[3] UK law – Medical Devices Regulations 2002 (SI 2002 No. 618, as amended (UK MDR 2002)) – defines “medical device” as:

An instrument, apparatus, appliance, material or other article, whether used alone or in combination, together with any software necessary for its proper application, which—

(a) is intended by the manufacturer to be used for human beings for the purpose of-

(i) diagnosis, prevention, monitoring, treatment or alleviation of disease,

(ii) diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,

(iii) investigation, replacement or modification of the anatomy or of a physiological process, or

(iv) control of conception; and

(b) does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, even if it is assisted in its function by such means,and includes devices intended to administer a medicinal product or which incorporate as an integral part a substance which, if used separately, would be a medicinal product and which is liable to act upon the body with action ancillary to that of the device.