Software as a medical device

The International Medical Device Regulators Forum (IMDRF) aims to accelerate international medical device regulatory convergence. It comprises representatives from the medical device regulatory authorities of Australia, Brazil, Canada, China, the EU, Japan, the Russian Federation, Singapore, South Korea and the US. Through the IMDRF, regulators reached a consensus on what software is considered a medical device. Regulators call it ‘software as a medical device’ (SaMD).1 As SaMD might be regulated in one country but not in another (see Figure 1), this is an important consideration for manufacturers’ go-to-market strategies and for the availability of SaMD across the world. This paper provides a comparison of how SaMD is regulated in the US and in the EU.

Software as a medical device