Last Updated on 22/08/2023 by Sarah Sarsby
Classification of Medical Device – EU Guidance Document: To determine if a product is a medical device and, if so, into which Class it fits (per Section 2 above), MHRA recommends this PDF Guidance Document from the original EU MDD legislation. On pp. 17-22 of the PDF, accessible via the “Download PDF rendition” link on the page, are flowcharts showing all device categories (Classes I-III) and definitions; pp. 23 ff. then list the rules governing each Class definition and gives examples of devices that fall into each category.
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.
MHRA – Borderlines with Medical Devices and Medicines: For more information on the distinction between medicines and medical device, see MHRA guidance Borderlines between medical devices and medicinal products.
MHRA – Borderline Products: Here MHRA set out how they make decisions on whether a product is a medical device for the purposes of UK legislation/regulation, and into which Class a medical device should fall, based on risk.
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:
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:
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:
Aids to daily living products that are not medical devices:
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.
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.