Risk-based evaluation of legacy user interfaces — post-production data review, hazard analysis, and residual risk re-evaluation — parallels standard usability engineering obligations.
Added by AMD1:2020 — normative Annex C pathway for User Interface of Unknown Provenance; previously no recognized compliance route for legacy or inherited interfaces.
UOUP boundary documentation and post-production data review evidence — any modified component reverts to full §5.1–5.9 and requires a clearly drawn boundary.
Maps to
IEC 62366: §5.10 USER INTERFACE OF UNKNOWN PROVENANCE
ISO 13485: §7.3.7 Design and development validation
Pre-QMSR Part 820 (legacy QSR): §820.30(g) Design validation.
Requirement text
Where a manufacturer has a User Interface — or part of a User Interface — for which adequate records of development using the IEC 62366-1:2015+AMD1:2020 CSV usability engineering process are not available (a User Interface of Unknown Provenance, or UOUP), the manufacturer may evaluate that UOUP according to Annex C instead of performing all of the requirements in §5.1 through §5.9. Compliance is checked by application of Annex C. If changes are made to any part of the UOUP, only the unchanged parts remain UOUP; changed parts are subject to the full §5.1–5.9 process.
Why this clause exists
Medical device manufacturers frequently inherit user interfaces — from acquisitions, platform consolidations, legacy product transitions, and third-party component integrations — for which the original human-factors development record either never existed under IEC 62366 or was lost. Without a recognized compliance pathway for these legacy interfaces, manufacturers faced a binary choice between performing a full retrospective §5.1–5.9 evaluation on interfaces that had years of field data but no development file, or claiming compliance without basis. Neither option served patient safety or regulatory credibility. IEC 62366-1 AMD1:2020 added §5.10 and Annex C to create a structured, evidence-based alternative: rather than reconstructing development history that does not exist, the manufacturer performs a post-production data review to detect use-error signals the field has already generated, conducts a focused hazard analysis and risk control verification, and documents a residual risk conclusion. This approach is grounded in the principle that an interface with substantial field use history has generated real evidence about its use-error profile — evidence that a prospective simulation study cannot produce — and that evidence should be systematically mined and acted upon rather than ignored. The UOUP boundary rule, requiring that any modified component revert to full §5.1–5.9, prevents manufacturers from shielding new interface changes behind legacy-pathway compliance.
What changed
Added by IEC 62366-1 AMD1:2020 (effective in the IEC 62366-1:2015+AMD1:2020 CSV consolidated edition). §5.10 introduces a normative alternative evaluation pathway for a User Interface of Unknown Provenance (UOUP) — defined as a user interface for which adequate records of development using the IEC 62366-1 usability engineering process do not exist (e.g., legacy UI components, inherited interfaces, or third-party components commercialized before the publication of IEC 62366-1:2015). Instead of performing all of §5.1 through §5.9, the manufacturer may evaluate such a UOUP via the requirements of normative Annex C, which relies on post-production surveillance data, a focused hazard analysis, risk control verification, and residual risk re-evaluation. If any modification is made to a UOUP component, the changed parts must revert to the full §5.1–5.9 process; only unmodified portions remain UOUP.