Research and planning
This page is for internal planning only. It will not be included in the final response to BSI.
Analysis
BSI could not find explicit results and conclusions about whether the IFU itself is usable. IEC 62366-1:2015+AMD1:2020 defines the user interface of a medical device as including accompanying documents; the IFU is therefore part of the user interface and within the scope of the summative evaluation per §5.9. The report contained data that demonstrates IFU usability but did not draw explicit conclusions from it.
The standards/GSPRs at stake are EN 62366-1 §5.9 and MDR Annex II §6.1(a)(b).
Applicable standard references
IEC 62366-1:2015+AMD1:2020
- §5.9: Summative evaluation shall provide objective evidence that the user interface can be used safely. The user interface includes accompanying documents (IFU).
- §3.17 (user interface): Means by which the user interacts with or is associated with the medical device — includes accompanying documents.
FDA "Applying Human Factors and Usability Engineering to Medical Devices" (2016)
- "The user interface consists of all points of interaction between the user and the device, including... device labeling."
- IFU is part of device labeling and therefore part of the user interface to be assessed.
MDR Annex II §6.1(a)(b)
- Technical documentation shall include the results of the summative evaluation and evidence of validation method.
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 | ITP results: ITP-T-01 "Access and read IFU" = 100%; ITP Knowledge Assessment = 100% |
| R-TF-025-004 Summative Evaluation Protocol | R-TF-025-004-Summative-Evaluation-Protocol.mdx | Session overview tables: HCP sessions include "Documentation Review" phase; ITP sessions include IFU access as first task |
| R-TF-001-006 IFU and Label Validation | legit-health-plus-version-1-1-0-0/information-provided-by-the-manufacturer/R-TF-001-006-IFU-and-Label-Validation.mdx | IFU developed as code, version-controlled, automated verification, multi-language support |
| EU IFU MDR | apps/eu-ifu-mdr/versioned_docs/version-1.1.0.0/ | The actual IFU content: intended purpose, clinical user manual, installation manual, precautions |
Evidence inventory
Evidence that already existed (but was not framed as IFU conclusions):
- ITP-T-01 ("Access and read the IFU"): 100% success (18/18) — ITPs located, accessed, and reviewed the IFU
- ITP Knowledge Assessment: 100% success across all 6 questions — all questions test comprehension of IFU content (endpoints, fields, error handling, version verification)
- HCP documentation review session phase: Per R-TF-025-004 §6, documentation review of the Clinical User Manual is a defined session phase and "considered a critical task" to be evaluated. Participants reviewed the Clinical User Manual before simulated use; all subsequently achieved 100% success on Scenarios 1 & 2
- HCP Knowledge Assessment Q1–Q3: Tests comprehension of IFU content. Q1 94.4% OK, Q2 100% OK, Q3 100% OK
- SUS scores: HCP 82.5 ("Excellent"), ITP 85.2 ("Excellent") — high perceived usability encompasses documentation comprehension
Gap analysis
This is a documentation gap, not an evidence gap. The summative evaluation tested IFU usability (ITP-T-01 is literally "Access and read the IFU") and the results are excellent. But the report never drew explicit conclusions about IFU usability as a distinct topic. BSI is right that this conclusion was missing.
| What existed | Why BSI missed it |
|---|---|
| ITP-T-01 "Access and read IFU" = 100% success | Not framed as an IFU usability conclusion; appeared only as one row in the ITP task results table |
| ITP Knowledge Assessment = 100% (tests IFU comprehension) | Not connected to IFU effectiveness conclusions |
| HCP documentation review during test sessions | No results documented about this review phase |
Response strategy
Point to existing evidence + add explicit conclusions to R-TF-025-007. ✅ DONE.
A new section has been added to R-TF-025-007: "Usability of Instructions for Use" containing:
- ✅ Assessment methods: Identifies which test items assessed IFU usability for each user group (ITP-T-01, ITP Knowledge Assessment, HCP documentation review phase, HCP simulated use, HCP Knowledge Assessment Q1–Q3)
- ✅ Results: Reports the results for each test item (100% success rates for ITP tasks and knowledge assessment; 100% HCP simulated use success after documentation review; Q1–Q3 94.4–100% OK)
- ✅ Q4 cross-reference: Findings related to Q4 are cross-referenced to the Root Cause Analysis and Residual Risk Assessment sections (avoids duplication with sub-items a and b)
- ✅ IFU development approach: Single sentence referencing R-TF-001-006 — version-controlled code repository, content consistency across languages, automated verification. Kept factual and brief to avoid opening questions about eIFU regulatory compliance.
- ✅ Conclusion: The IFU is usable and effective for both intended user groups, providing objective evidence per IEC 62366-1 §5.9
Key regulatory arguments used:
- IEC 62366-1 defines user interface as including accompanying documents — IFU is in scope of §5.9
- Protocol (R-TF-025-004, §6) explicitly defines documentation review as a "critical task" to be evaluated — we are not retroactively adding scope, we are drawing conclusions from planned test items
- HCP success on simulated use after documentation review is valid indirect evidence of IFU usability per FDA HF guidance (users demonstrated ability to apply IFU information to correctly operate the device)
- ITP-T-01 is direct evidence of IFU accessibility and readability
- ITP Knowledge Assessment is direct evidence of IFU comprehension (100% success on 6 questions covering IFU content)
Priority: Medium. ✅ COMPLETED. The evidence was strong and already in the report; it needed explicit framing.
Cross-NC connection: QC and Q2 are two sides of the same coin
QC and Q2 (labeling/IFU V&V) are not independent findings — they reflect the auditor systematically checking the complete V&V story for the IFU:
- Q2 = Verification: Are the 26 labeling requirements (LR-XXXX) present and correct in the IFU/label? Addressed by a per-requirement content review table in R-TF-001-006.
- QC = Validation: Does the IFU actually work for users? Under IEC 62366-1 §5.9, usability testing of the IFU is the mechanism by which IFU validation is demonstrated. This is why the auditor specifically looked for explicit conclusions about IFU usability — they see it as the validation leg of the labeling V&V required by Q2.
The auditor's question in Q2 used the phrase "verified and/or validated." The verification part (content completeness) is addressed by Q2's per-requirement traceability. The validation part (content effectiveness for users) is what QC addresses. The auditor found neither explicitly documented, which is why both NCs were raised.
Our responses already cross-reference each other (Q2 cites R-TF-025-007 as validation evidence per EN 82304-1 §5.3; QC cites R-TF-001-006 for content verification). Keeping this alignment consistent across both responses strengthens the overall narrative: together they demonstrate the IFU has the right content (Q2) AND that it works (QC).