Notice: Publication of the Guidance Document - Guidance for the Risk-based Classification System for In Vitro Diagnostic Devices (IVDDs) (English, HTML)

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Publisher-reported update

2023-12-24

This guidance document clarifies the application of the risk classification rules for IVDDs set out in Part II of Schedule I of the Medical Devices Regulations, and was recently rewritten to include updated examples and to conform to Good Guidance Practices.

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