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Schedule 2 — Classification rules

Regulatory basis

This page covers official UK legislation. Always verify against the current consolidated text at legislation.gov.uk.

Disclaimer

This site provides general information only and does not constitute legal or regulatory advice.

Overview​

Schedule 2 of the UK MDR 2002 contains the 18 classification rules for general medical devices. These rules are applied by manufacturers to determine whether a device is Class I, IIa, IIb, or III.

The 18 classification rules​

Schedule 2 contains 18 rules grouped into four sections:

  • Rules 1–4: Non-invasive devices
  • Rules 5–8: Invasive devices
  • Rules 9–12: Active devices (including software)
  • Rules 13–18: Special rules

The highest class produced by any applicable rule applies. See Classification rules — Schedule 2 in detail for a full rule-by-rule walkthrough.

Classification rules for AIMDs​

AIMDs are classified under Part II — there is only one risk tier for AIMDs, and all require full UKAB assessment.

Classification rules for IVDs​

IVDs are classified under Part III, Annex II (List A, List B) and the self-test designation — not Schedule 2. See IVD classification.

Official references​

ReferenceDescription
UK MDR 2002, Schedule 2Full text — 18 classification rules
EU MDD 93/42/EEC, Annex IXSource of the UK classification rules (for comparative reference)