How classification works
How medical device classification works under the UK Medical Devices Regulations 2002 — the rule-based system for general devices (Classes I, IIa, IIb, III), active implantable devices (AIMD), and IVDs (List A, List B, Self-test, General) — and why classification determines everything else.
Class I · IIa · IIb · III
Overview of the four risk classes for general medical devices under the UK Medical Devices Regulations 2002 — what defines each class, UKAB requirements, conformity assessment routes, and practical examples of devices in each class.
Classification rules — Schedule 2 in detail
A rule-by-rule walkthrough of all 18 classification rules in Schedule 2 of the UK Medical Devices Regulations 2002, with the device characteristics each rule targets and practical examples.
IVD classification — List A · List B · Self-test · General
IVD medical device classification under Part III of the UK Medical Devices Regulations 2002 — Annex II List A, Annex II List B, self-test devices, and general IVDs, with conformity assessment requirements for each category and comparison with EU IVDR Class A–D.
Active implantable medical devices (AIMD)
Active implantable medical devices under Part II of the UK Medical Devices Regulations 2002 — definition, scope, Essential Requirements, conformity assessment, and the distinction from Class III general medical devices.
Software & SaMD classification
How standalone software is classified as a medical device under the UK Medical Devices Regulations 2002 — the qualification test, applicable classification rules, MHRA guidance on AI and machine learning, and comparison with the EU MDR/MDCG approach.
Borderline & combination products
How MHRA approaches products that sit on the boundary between medical devices and other regulatory frameworks — medicines, cosmetics, biocides — and how drug-device combination products are regulated under the UK Medical Devices Regulations 2002.