Maps to
QMSR / ISO 13485: §820.40
ISO 13485: §4.2.4
IEC 62366: §4.2
Requirement text
The manufacturer shall establish and maintain a usability engineering file containing all usability engineering outputs and providing a record of the usability engineering activities performed. The file must be a traceable, complete record of the usability work for the device.
What changed
IEC 62366-1:2015 replaced the 2007 first edition with a major restructuring. The standard was split into Part 1 (normative requirements) and Part 2 (IEC TR 62366-2, informative guidance and methods). The scope broadened to include hazards of all types including psychological hazards, not just direct physical hazards.
The standard introduced a formative/summative evaluation framework not present in 2007. The 2007 requirement to identify primary operating functions was removed — instead, the 2015 version mandates identification and evaluation of hazard-related use scenarios. A concept of User Interface of Unknown Provenance (UOUP) was added, allowing simplified evaluation for legacy or off-the-shelf interfaces based on post-market data.
Amendment 1 (2020) further refined the standard: it updated the ISO 14971 reference to the 2019 edition, introduced bidirectional exchange between risk management and usability engineering (previously one-directional), added training as a third priority risk control measure alongside information for safety, introduced the concept of 'use difficulty' (close calls and observed problems that don't result in actual use errors), and replaced 'action error' with 'physical mismatch' to encourage broader analysis of use problems.
Atomic constraints
- •A usability engineering file must exist for the device, collecting all usability outputs in one retrievable location.
- •The file must include the Usability Evaluation Plan, Hazard-Related Use Scenarios, and Usability Evaluation Report.
- •The file must be maintained throughout the device lifecycle and updated when usability activities are conducted.
- •The file must enable traceability from use scenarios to evaluation activities and results.
Common gaps
Usability Engineering File incomplete or missing
majorApproximately 90% of human factors testing reports submitted to the FDA in 510(k) submissions are deficient because the submission includes only the final summative testing report. FDA expects the full Usability Engineering File including the Use-Related Risk Analysis, formative evaluation records, and the iterative design process that led to the final design.
Evidence signals
- •
FILE_EXISTS
Usability.*Evaluation.*Plan|Usability.*Evaluation.*Report|Usability.*File|Hazard.*Use.*Scenario
- •
CONTENT_MATCH
Does this document or set of documents collectively constitute a usability engineering file containing evaluation plans, hazard-related use scenarios, and evaluation results that provide a traceable record of all usability activities conducted?
Audit defense
The Usability Engineering File for [your product] consists of the Usability Evaluation Plan ([your document ID]), Hazard-Related Use Scenarios List, and Usability Evaluation Report. These documents collectively provide the IEC 62366-1 section 4.2 file, with traceability from use scenarios through evaluation results.