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See more information on what a medical device is in the UK MDR 2002. If you are manufacturing a medical device you must follow the specific Part for your type of product as it sets out the essential requirements the product must meet in the interest of patient safety.

investigation, replacement or modification of the anatomy or of a physiological process, orĪ medical device does not achieve its main intended action by pharmacological, immunological or metabolic means although it can be assisted by these.Ī medical device 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.

diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap.

diagnosis, prevention, monitoring, treatment or alleviation of disease.

You need to decide if your product is a medical device before you go through the compliance process.Īccording to the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002), a medical device is described as any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnosis or therapeutic purposes or both and necessary for its proper application, which is intended by the manufacturer to be used for human beings for the purpose of:

For information on how to comply with the legal requirements in Northern Ireland, please see our guidance on Northern Ireland.

This guidance is specific to the provisions in Great Britain (England, Wales and Scotland). This guidance outlines the steps you need to follow before your product can be placed on the Great Britain market with a UKCA mark.

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