QMSR / ISO 13485 §820.30(g)

Maps to

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 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.

What changed

Atomic constraints

• •The manufacturer must establish a Use Specification (per §5.1) for the UOUP and store it in the Usability Engineering File (Annex C §C.2.1).
• •The manufacturer must review available post-production information — including complaints, field reports, and incident records — for use errors, near-incidents, or hazardous situations attributable to usability problems in the UOUP (Annex C §C.2.2).
• •Identified use errors and near-incidents from post-production review must be stored in the Usability Engineering File and addressed in the hazard analysis and risk control steps (Annex C §C.2.2).
• •The manufacturer must review the risk analysis of the medical device with UOUP to ensure hazards and hazardous situations associated with usability have been identified and documented (Annex C §C.2.3).
• •The manufacturer must verify that adequate risk control measures have been implemented for all identified hazards and hazardous situations, and that all risks are reduced to an acceptable level (Annex C §C.2.4).
• •If risk control requires changes to any part of the user interface, those changed parts are no longer UOUP and must be evaluated under §5.1–5.9 (Annex C §C.2.4).
• •Based on findings from the hazard analysis and risk control steps, the manufacturer must re-evaluate overall residual risk per ISO 14971:2019 §7.3 and document the result in either the Usability Engineering File or the Risk Management File (Annex C §C.2.5).
• •The UOUP evaluation pathway is only available when adequate records of prior §5.1–5.9 development do not exist; it cannot be applied to UI components developed after IEC 62366-1:2015 publication where such records should be available.

Evidence signals

• •

  FILE_EXISTS

  UOUP|Unknown.*Provenance|Annex.*C.*Evaluation|Legacy.*Interface.*Evaluation

• •

  CONTENT_MATCH

  Does this document evaluate a legacy, inherited, or third-party user interface component using a post-production information review and risk analysis approach, rather than the standard formative/summative usability engineering process? Does it reference a User Interface of Unknown Provenance (UOUP) or an Annex C evaluation pathway?

Audit defense

The UOUP Evaluation for [your product] (Doc ID: [your document ID]) documents the scope of interface components assessed under IEC 62366-1:2015+AMD1:2020 CSV Annex C, including a review of all available post-production information for use-related incidents, a usability-focused hazard analysis, risk control verification, and residual risk re-evaluation per ISO 14971:2019 §7.3. Components modified after the evaluation boundary date have been subjected to the full §5.1–5.9 process.