EU AI ActMDR/IVDRSaMD
EU AI Act Passes: Immediate Implications for AI/ML Medical Devices under MDR/IVDR
A new layer of regulation is here. How does the Artificial Intelligence Act interact with existing medical device frameworks?
EU AI Act Overview
The European Parliament has officially adopted the AI Act. This regulation classifies AI systems according to their risk.
Impact on MedTech
Software as a Medical Device (SaMD) utilizing AI will mostly fall into the High-Risk category. This necessitates:
- Conformity Assessment: Must be integrated with the MDR process.
- Quality Management: Enhanced requirements for data training sets.
