Description
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.
Resources
| Name | Format | Description | Link |
|---|---|---|---|
| Notice: Publication of the Guidance Document - Guidance for the Risk-based Classification System for In Vitro Diagnostic Devices (IVDDs) | HTML | Open resource | |
| Notice: Publication of the Guidance Document - Guidance for the Risk-based Classification System for In Vitro Diagnostic Devices (IVDDs) | HTML | Open resource |