Medsafe RiskRisk Classification
Risk Classification is the official Medsafe identifier for “Risk Classification of Medical Devices”. Risk Classification is the official identifier Medsafe uses for this instrument.
- Instrument
- Risk
- Full name
- Risk Classification
- Category
- Classification
- Authority source
- English
- Readable HTML
- 4 articles · 1 language version
- Published
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Risk Classification of Medical Devices
Medsafe explainer of the three-tier device risk-classification system (Classes I/II/III) applied through the 22 classification rules of Schedule 2 to the Medicines (Database of Medical Devices) Regulations 2003: explanation of the risk classes, the rules of risk classification, and how to apply the rules. The companion classification rules themselves are carried by the corpus Regulations 2003 extract (schedule-2 clause anchors). Page revised 10 May 2011 per its own stamp; ingested from the exact official HTML with sec-1..sec-3 anchors.
Risk Classification is the official identifier Medsafe uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.