EnrichMyCare registers Class I Software as a Medical Device with the MHRA

Enrich Digital Technologies Ltd, developer of EnrichMyCare, has registered relevant clinician-facing EnrichMyCare software functionality with the Medicines and Healthcare products Regulatory Agency (MHRA) as Class I Software as a Medical Device (SaMD).

The registration, completed in June 2026, forms part of EnrichMyCare’s wider approach to responsible clinical AI and medical-device governance.

EnrichMyCare uses AI-enabled clinical intelligence to support clinicians with activities including triage and structured clinical summarisation. The design principle is clear: AI can organise, summarise and support interpretation of clinical information, while clinical decisions remain with the responsible professional.

The regulatory framework supporting the technology includes clinical risk management, DCB0129 clinical safety processes and software lifecycle controls alongside the requirements of the UK Medical Devices Regulations 2002.

MHRA registration is a regulatory registration and should not be interpreted as MHRA certification, approval or endorsement.

EnrichMyCare’s MHRA registration reference is 2026060201497180.

The milestone supports EnrichMyCare’s continued work with NHS organisations to introduce AI-enabled clinical intelligence within appropriately governed clinical pathways.

This article offers general guidance and is not a substitute for advice from your child's clinical team. If you have concerns about your child's diagnosis or wellbeing, please speak to your GP, paediatrician, or care coordinator.