Software as a Medical Device (SaMD): US and EU comparison
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 consensus on what software is considered a medical device. Regulators call it ‘software as a medical device’ (SaMD). As SaMD might be regulated in one country but not in another, 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.
Topics covered in this Whitepaper include:
- Software as a Medical Device
- Placement on the market
- Regulatory Requirements: FDA
- Regulatory Requirements: EU
- Differences in how the classification process works
- Differences in length of regulatory approval process
