A simple interactive tool designed to help you determine the appropriate risk classification for your Software as a Medical Device (SaMD) under UK regulations.

Educational Purposes Only: This tool is provided for educational and informational purposes only. The results should not be considered as definitive medical device classification. Always consult with SaMD regulatory specialists for professional guidance on classification and compliance requirements.

SaMD Risk-Based Classification

Software as a Medical Device (SaMD) is subject to classification based on the risk it poses to the patient. This classification determines the regulatory pathway that the SaMD must undergo to ensure safety and effectiveness.

For more comprehensive information on SaMD classification, please visit our documentation page.

Question 1 of 10 0% Complete

Useful Resources

© Yoctobe – Beta 1.0.0

Updated: April 1, 2025