Regulatory Milestone: MHRA Guidance on "SaMD" (Software...

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2026-01-20 10:06:23 -

Regulatory Milestone: MHRA Guidance on "SaMD" (Software as a Medical Device)

New regulatory guidance released by the MHRA in collaboration with NICE in late 2025 has redefined the UK Digital Mental Health Market landscape for 2026. The guidance clarifies that any digital mental health technology (DMHT) that diagnoses or treats conditions using complex software must now be regulated as Software as a Medical Device (SaMD). This change divides the market into two distinct...

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