Policy & Regulatory Landscape
The regulatory environment for AI medical devices is evolving rapidly across multiple jurisdictions simultaneously. We track, analyse, and respond to this landscape — and work to improve it.
Center for Devices and Radiological Health
The FDA has authorised over 900 AI/ML-enabled medical devices, with approximately 80% cleared via the 510(k) pathway. We track PCCP guidance, SaMD frameworks, and post-market surveillance proposals.
High-risk classification · MDR
Mandatory conformity assessment for high-risk health AI. We monitor notified body designation and the interaction between the AI Act and the Medical Device Regulation.
ISO · IEC · ITU · WHO
We engage with international standards development and contribute to WHO guidance — aiming to reduce fragmentation that burdens responsible developers and health systems equally.
Our Regulatory Engagement
We submit formal responses to proposed guidance documents, participate in public consultation processes, and publish our positions in full. We do not engage in ex-parte communications or seek to influence policy outcomes through channels not available to any other public-interest participant.
Contact our policy team