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Start by determining your device's risk class. This decision shapes your entire regulatory pathway, including whether you need a UK Approved Body.

Medical device classification system

Risk-based classification system for medical devices determining regulatory pathway.

Class I (lowest risk): Non-invasive devices with minimal risk — self-certification by manufacturer (e.g., bandages, wheelchairs, stethoscopes)
Class Is (sterile, low risk): Sterile low-risk devices — self-certification plus UK Approved Body assessment for sterility aspects (e.g., sterile bandages, sterile surgical gloves)
Class Im (measuring, low risk): Low-risk devices with measuring function — self-certification plus UK Approved Body for metrological aspects (e.g., non-invasive thermometers, graduated syringes)
Class IIa (low-medium risk): Short-term invasive devices and diagnostic equipment — UK Approved Body assessment required (e.g., hearing aids, dental crowns, blood pressure monitors)
Class IIb (medium-high risk): Long-term invasive and surgically invasive devices — UK Approved Body full assessment required (e.g., ventilators, blood bags, condoms)
Class III (highest risk): Devices contacting heart or CNS, containing medicinal substances, or made from animal tissue — UK Approved Body full design examination and QMS assessment (e.g., heart valves, hip implants, coronary stents, pacemakers)
Active implantable medical devices (AIMD): Devices totally or partially introduced into the human body and intended to remain — UK Approved Body full assessment required (e.g., cardiac pacemakers, cochlear implants, neurostimulators)
Classification basis: Classification determined by intended purpose, invasiveness, duration of body contact, and whether device is active — rules in Annex IX of retained Directive 93/42/EEC

Medical device classification guidance (opens in a new tab)

Step 1: Classify your device

Classify your medical device for the GB market