Maps to
IEC 62366: §5.7 Establish USER INTERFACE EVALUATION plan
ISO 13485: §7.3.6 Design and development verification
Pre-QMSR Part 820 (legacy QSR): §820.30(f) Design verification.
Requirement text
The manufacturer shall plan both formative and summative usability evaluation activities. The evaluation plan must specify the evaluation methods, participant criteria, settings, and how results will be analyzed. Per AMD1:2020 §5.7.3(e), summative evaluation planning must specify the method of collecting data for subsequent analysis of both use errors AND use difficulties, justify participant grouping into distinct user groups, and define correct use for each hazard-related use scenario. Summative evaluation planning must ensure coverage of all hazard-related use scenarios.
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.
Amendment 1 (IEC 62366-1:2015+AMD1:2020 CSV) made three substantive normative additions to §5.7.3(e): (1) the summative evaluation plan must specify the method of collecting data during the usability test for subsequent analysis of observed use errors AND use difficulties (near-misses/close calls); (2) the plan must justify how test participants are grouped into distinct user groups for the purpose of determining participant numbers; and (3) the plan must define correct use for each hazard-related use scenario. In 2015, only use-error analysis and participant profile criteria were required; these three additions tightened the planning obligation. Also changed: 'USER PROFILE' terminology in plan requirements was updated to 'USER GROUP', and specimen wording in examples was adjusted accordingly (editorial). ISO 14971 cross-references updated from 2007 to 2019 edition.
Atomic constraints
- •A Usability Evaluation Plan must be documented before evaluations begin.
- •The plan must describe formative evaluation methods and their schedule.
- •The summative evaluation plan must specify the user profile for test participants.
- •All hazard-related use scenarios must be covered by summative evaluation test cases.
- •The plan must specify a minimum number of test participants and the test setting.
- •The plan must describe how use errors and hazards observed during testing will be analyzed.
- •The summative evaluation plan must specify the method of collecting data during the usability test for subsequent analysis of both observed use errors and use difficulties (per §5.7.3, AMD1:2020).
- •The summative evaluation plan must justify how test participants are grouped into distinct user groups for the purpose of determining the number of test participants (per §5.7.3(e), AMD1:2020).
- •The summative evaluation plan must define correct use for each hazard-related use scenario included in the summative evaluation (per §5.7.3(e), AMD1:2020).
Common gaps
Formative evaluation used to skip summative testing
majorCompanies mistakenly believe they can skip summative testing by only doing formative evaluations. While you can reduce scope by leveraging data from a predicate device (Clause 5.10), you must provide a technical rationale explaining why design changes do not affect previously validated critical tasks. Without this rationale, summative evaluation is required.
Evidence signals
- •
FILE_EXISTS
Usability.*Evaluation.*Plan|Usability.*Plan|Usability.*Test.*Plan
- •
CONTENT_MATCH
Does this document plan both formative and summative usability evaluation activities, specifying participant criteria matching the intended user profile, test methods, settings, and confirming that all hazard-related use scenarios are covered by test cases?
Audit defense
The Usability Evaluation Plan for [your product] (Doc ID: [your document ID]) documents the formative evaluation schedule and summative evaluation design, including participant criteria, test setting, and a traceability matrix confirming that all hazard-related use scenarios are covered by summative test cases.