Software as a Medical Device (SaMD): Key Definitions
Establishes the term "Software as a Medical Device" and the vocabulary regulators now share for it — what counts as SaMD, how it differs from software embedded in a device, and the concepts subsequent SaMD guidance builds on.
Software intended for a medical purpose that performs that purpose without being part of a hardware medical device.
- 01Correct determination of whether a product is SaMD before selecting a pathway
- 02Consistent use of the shared vocabulary in technical documentation
IMDRF/SaMD WG/N10: frequently asked questions
Quick answers to common questions about IMDRF/SaMD WG/N10.
What is IMDRF/SaMD WG/N10?
IMDRF/SaMD WG/N10 — Software as a Medical Device (SaMD): Key Definitions — is a guidance issued by the International Medical Device Regulators Forum. Establishes the term "Software as a Medical Device" and the vocabulary regulators now share for it — what counts as SaMD, how it differs from software embedded in a device, and the concepts subsequent SaMD guidance builds on.
Who does IMDRF/SaMD WG/N10 apply to?
Software intended for a medical purpose that performs that purpose without being part of a hardware medical device.
What are the key requirements of IMDRF/SaMD WG/N10?
IMDRF/SaMD WG/N10 requires, among other things: Correct determination of whether a product is SaMD before selecting a pathway; Consistent use of the shared vocabulary in technical documentation.
When was IMDRF/SaMD WG/N10 last updated?
The current version of IMDRF/SaMD WG/N10 dates from December 2013.
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/N10 — or any GxP requirement — is revised, recalled against, or clarified by new guidance, the Weekly GxP Briefing surfaces it. Free, one email a week.