Software as a medical device - A comparison of the EU’s approach with the US’s approach

Whitepaper Software as a Medical Device

The International Medical Device Regulators Forum (IMDRF) aims to accelerate international medical device regulatory convergence.​ Through the IMDRF, regulators reached consensus on what software is considered a medical device. Regulators call it ‘software as a medical device’ (SaMD). This paper provides a comparison of how SaMD is regulated in the US and in the EU.