AI/GxPFdaUnited Kingdom
MHRA updates SaMD/AIaMD guidance, highlighting PCCP and transparency principles
Relevant for
Signal Management LeadRegulatory Intelligence LeadMedical Device Vigilance LeadPV Quality Lead+2 more
Action needed
Ask the safety/device vigilance and PV CSV leads to: (1) confirm whether any marketed/fielded SaMD/AIaMD uses adaptive ML or planned updates that would fit a PCCP-like approach; (2) review current change-control SOPs and technical documentation to ensure change governance and transparency artifacts are captured and retrievable; (3) verify post-market/vigilance processes explicitly account for algorithm updates (e.g., monitoring after updates, escalation criteria).
Process impact
Risk ManagementDevice VigilanceInspection Readiness
SOP impact
5 SOPs may need review
Urgency: HighConfidence: medium
Read impact brief →