Medical devices classification tool draft/

This tool is intended to assist you with the classification of your medical device by walking through the classification rules found in Schedule 1 of the Medical Devices Regulations.

Classification Tool

For additional guidance, explanations and examples of how to apply the classification rules, please refer to the following guidance documents:

• Guidance Document: Guidance on the Risk-based Classification System for Non-In Vitro Diagnostic Devices (non-IVDDs)
• Guidance Document Software as a Medical Device (SaMD): Definition and Classification
• Guidance Document Software as a Medical Device (SaMD): Classification Examples
• Guidance Document: Guidance for the Risk-based Classification System for In Vitro Diagnostic Devices (IVDDs)