Updated MDCG Guidance on the Classification of Medical Devices: No Changes for SaMD

The MDCG published Revision 1 ofthe “Guidance on the Classification of Medical Devices.” However, it contains only structural and editorial changes, as well as updated decision trees to better illustrate the classification rules and new examples.

You can find the new guideline under MDCG 2021-24 Guidance on the Classification of Medical Devices