Research and planning

Internal working document

This page is for internal planning only. It will not be included in the final response to BSI.

Analysis

BSI found no conclusions about whether the safety information (warnings, precautions, intended use statements) communicated through the IFU and labeling is effective. This sub-item is explicitly linked to sub-item b: BSI's position is that if 33% of participants didn't understand the device is not diagnostic, then the information for safety regarding intended use is not clearly effective.

The standards/GSPRs at stake are GSPR 17.2 and EN 62366-1 §5.9.

Relevant documents

Document	Path	Key content
R-TF-025-007 Summative Evaluation Report	R-TF-025-007-Summative-Evaluation-Report/R-TF-025-007-Summative-Evaluation-Report.mdx	HCP Q1–Q4 results, ITP results, SUS/AttrackDiff scores
EU IFU MDR — Precautions	apps/eu-ifu-mdr/versioned_docs/version-1.1.0.0/clinical-user-manual/precautions.mdx	Residual risks with mitigation strategies; safety-critical statements
EU IFU MDR — Intended Purpose	packages/reusable/snippets/IntendedPurpose.mdx	Device description, intended users, operating principle
EU IFU MDR — NotUse component	packages/reusable/snippets/NotUse.mdx	Safety information about what the device is NOT
Labeling Requirements	apps/qms/src/components/LabelingRequirements/labeling-requirements.json	LR-7MN (intended purpose and device description), other safety-related LRs

Evidence that exists (but is not framed as information-for-safety conclusions):

• HCP Q4 (intended use understanding): 66.7% immediately correct (OK), improving to 94.4% when counting CCs and UDs as eventually correct (only 1 UE)
• HCP Q1 (what information the report shows): 94.4% OK — participants understood device output
• HCP Q2 (malignancy probability): 94.4% OK — participants correctly read quantitative safety data
• HCP Q3 (conditions detected): 100% OK — participants correctly identified conditions listed
• ITP: 100% success across all tasks and knowledge assessment — safety information is fully effective for ITPs
• SUS scores (82.5 HCP, 85.2 ITP): Both "Excellent" — high perceived usability includes comprehension of safety documentation
• Precautions section in IFU: Documents residual risks with HCP-validated mitigation strategies
• "Serious incident" reporting requirement in IFU: Instructs users to report incidents to manufacturer and competent authority

Gap analysis

This is a documentation gap tied to sub-item b. The summative evaluation tested safety information effectiveness through the Knowledge Assessment (especially Q4), but the report does not:

1. Identify which test items assess safety information effectiveness
2. Draw explicit conclusions about whether information for safety is effective
3. Discuss the Q4 findings in the context of safety information adequacy

The link to sub-item b is direct: if the RCA (sub-item a) concludes that the Q4 results indicate acceptable residual risk, then sub-item d is also addressed. If the RCA reveals a gap in safety information, additional IFU updates may be needed.

Response strategy

Provide the missing analysis connecting test results to safety information effectiveness.

Add a new section to the report: "Effectiveness of Information for Safety" that:

1. Identifies which test items assess safety information effectiveness (HCP Q1–Q4, ITP Knowledge Assessment)
2. Reports the results aggregated by safety-relevant topic
3. Concludes on whether information for safety is effective:
   • For device output interpretation (Q1–Q3): clearly effective (94.4–100% OK)
   • For intended use understanding (Q4): effective for 94.4% of participants when CCs and UDs are correctly classified; root cause analysis (per sub-item a) demonstrates residual risk is acceptable
   • For ITP user group: fully effective (100%)
4. References the RCA and residual risk assessment from sub-item a for the Q4 findings

Voluntary enhancement (concrete specification):

As an additional measure to strengthen safety information effectiveness — not because the current IFU is inadequate, but as a proactive improvement informed by the summative evaluation findings — we will make the following specific change to the IFU:

• Add a dedicated "Important safety information" callout to the Clinical User Manual, immediately after the intended purpose section, containing an explicit statement such as: "The device output is not a clinical diagnosis. The probability distributions and severity scores are decision-support information that must be interpreted by a qualified healthcare professional in the context of the patient's complete clinical picture."
• This callout will use visual formatting (warning box / highlighted panel) to ensure it is prominent and not overlooked during IFU review.
• The corresponding labeling requirement (LR-7MN) already includes "The device outputs are intended to support, not replace, clinical judgment" — the enhancement makes this more visually prominent rather than adding new content.

This is framed in the response as: "Informed by the summative evaluation findings, we have enhanced the prominence of the non-diagnostic safety information in the IFU. This voluntary improvement demonstrates our commitment to continuous safety improvement per EN 62366-1 and ISO 14971."

Priority: Medium (addressed jointly with sub-items a and b through the RCA/residual risk sections). ✅ COMPLETED.

Actions completed:

1. ✅ "Effectiveness of Information for Safety" section added to R-TF-025-007. Maps each knowledge assessment question to a safety-relevant topic, presents aggregated results per user group, and draws explicit conclusions on effectiveness. Cross-references RCA and residual risk assessment for Q4 findings.
2. ✅ "Important Safety Information" page added to the Clinical User Manual (IFU, § Clinical User Manual > Important Safety Information). Contains a visually prominent :::warning admonition stating the device output is not a clinical diagnosis, followed by guidance on understanding the probabilistic output and when to use the device. File: apps/eu-ifu-mdr/versioned_docs/version-1.1.0.0/clinical-user-manual/important-safety-information.mdx (sidebar_position 0, first page in Clinical User Manual).
3. ✅ Spelling errors fixed in precautions.mdx: "sympthoms" → "symptoms", "recomended" → "recommended", "alognside" → "alongside".