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Software as a Medical Device (SaMD)

MDACS · IMDRF SaMD framework · HK approach

Is Your Software a Medical Device?​

Likely yes if: diagnoses disease from patient data · predicts patient risk · recommends treatment · monitors patient condition · controls hardware device parameters

Likely no if: administrative/billing only · general wellness without medical claims · EHR storage/retrieval without clinical decision support

Classification​

SaMD is classified via TR-003 (non-IVD) or TR-004 (IVD SaMD) based on:

  • Severity of the clinical condition addressed
  • Significance of software output to clinical decision-making
  • Whether software drives or merely informs a clinical decision

High-risk diagnostic AI → typically Class III or IV. General clinical support tools → may be Class II.

Key Documentation for SaMD​

  • IEC 62304 — software lifecycle processes
  • IEC 62366-1 — usability engineering
  • ISO 14971 — risk management applied to software
  • Algorithm validation (for AI/ML) — training data, performance metrics, bias assessment
  • Cybersecurity risk management plan

AI/ML Adaptive Algorithms​

For AI/ML that adapts post-deployment:

  • Define the learning boundary — what changes are within pre-approved scope
  • Significant changes beyond the boundary require MDD change notification
  • Consider a Predetermined Change Control Plan approach for anticipated future updates