Response

d. R-TF-025-007 (Summative Evaluation Report) has been updated with a new section, "Effectiveness of Information for Safety," which presents results and conclusions regarding the effectiveness of safety information communicated through the IFU and labeling. This section was required by EN 62366-1 §5.9 and committed to in R-TF-025-004, §14.7 (Data Analysis). Red-lined documentation is provided.

The summative evaluation assessed information-for-safety effectiveness through the Knowledge Assessment (HCP Q1–Q4, ITP Q1–Q6), which tested participants' comprehension of safety-relevant content after reviewing the IFU and using the device. The updated section maps each test item to a safety-relevant topic and presents aggregated conclusions:

• Understanding of device output content (HCP Q1): 94.4% OK (17/18). Participants correctly identified the information produced by a device report, demonstrating effective comprehension of output-related safety information.
• Interpretation of malignancy probability (HCP Q2): 100% OK (18/18) after scoring verification (see sub-item a). Participants correctly extracted and interpreted quantitative risk stratification data from the report.
• Identification of detected conditions (HCP Q3): 100% OK (18/18). All participants correctly identified the conditions listed in a device report.
• Understanding of non-diagnostic intended purpose (HCP Q4): 72.2% OK (13/18) after scoring verification (see sub-item a). Including close calls and use difficulties — participants who demonstrated correct understanding through self-correction or qualified responses — 94.4% (17/18) demonstrated effective comprehension per IEC 62366-1. The root cause analysis and residual risk assessment (sub-item a) concluded that the single use error (5.6%) is an isolated finding that does not indicate a systematic safety information deficiency.
• ITP user group (Q1–Q6): 100% OK across all 6 questions and all 18 participants.

The section concludes that information for safety is effective for both intended user groups. For device output interpretation (Q1–Q3), effectiveness is clearly demonstrated (94.4–100%). For the non-diagnostic intended purpose (Q4), residual risk is acceptable per the analysis in sub-item a. For the ITP user group, effectiveness is fully demonstrated.

As a voluntary enhancement, a dedicated "Important safety information" section has been added to the Clinical User Manual (IFU), immediately following the intended purpose section. This section presents the non-diagnostic nature of the device in a visually prominent warning format, explicitly stating that device outputs are clinical decision support information that must be interpreted by a qualified healthcare professional and do not constitute a clinical diagnosis. Red-lined documentation of the IFU change is provided.

Relevant commits

• 3045fa6 (2026-03-01, Taig Mac Carthy): Created apps/eu-ifu-mdr/versioned_docs/version-1.1.0.0/clinical-user-manual/important-safety-information.mdx — the voluntary IFU enhancement. Fixed three spelling errors in precautions.mdx ("sympthoms"→"symptoms", "recomended"→"recommended", "alognside"→"alongside").
• 7804ad3 (2026-03-01, Taig Mac Carthy): Added "Effectiveness of Information for Safety" section to R-TF-025-007-Summative-Evaluation-Report.mdx.