SaMD: Possible Framework for Risk Categorization and Corresponding Considerations
Proposes the risk-categorisation framework for Software as a Medical Device: category is driven by the significance of the information the software provides to a healthcare decision and by the state of the healthcare situation or condition it addresses.
All SaMD. The framework is the conceptual basis several jurisdictions have drawn on when setting software classification and evidence expectations.
- 01Documented SaMD categorisation with the reasoning behind both axes
- 02Evidence and lifecycle rigour proportionate to the category
- 03Reconciliation of the framework against each market’s binding classification rules
IMDRF/SaMD WG/N12: frequently asked questions
Quick answers to common questions about IMDRF/SaMD WG/N12.
What is IMDRF/SaMD WG/N12?
IMDRF/SaMD WG/N12 — SaMD: Possible Framework for Risk Categorization and Corresponding Considerations — is a guidance issued by the International Medical Device Regulators Forum. Proposes the risk-categorisation framework for Software as a Medical Device: category is driven by the significance of the information the software provides to a healthcare decision and by the state of the healthcare situation or condition it addresses.
Who does IMDRF/SaMD WG/N12 apply to?
All SaMD. The framework is the conceptual basis several jurisdictions have drawn on when setting software classification and evidence expectations.
What are the key requirements of IMDRF/SaMD WG/N12?
IMDRF/SaMD WG/N12 requires, among other things: Documented SaMD categorisation with the reasoning behind both axes; Evidence and lifecycle rigour proportionate to the category; Reconciliation of the framework against each market’s binding classification rules.
When was IMDRF/SaMD WG/N12 last updated?
The current version of IMDRF/SaMD WG/N12 dates from September 2014.
Live openFDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.
Track the standards that move
When IMDRF/SaMD WG/N12 — or any GxP requirement — is revised, recalled against, or clarified by new guidance, the Weekly GxP Briefing surfaces it. Free, one email a week.