Response

The IFU and label content was reviewed during the Phase 5 Product Validation design review (R-TF-012-026 Product Validation Phase 5 Checklist, section "Information Provided by Manufacturer"), which confirmed IFU completeness, intended use, contraindications, warnings, technical specifications, and label regulatory information. However, that design review verified content at the regulatory-checklist level rather than tracing each of the 26 individual labeling requirements defined in R-TF-012-037. This per-requirement traceability has now been added. The updated documentation is described below.

Verification and validation plan. The verification and validation of labeling and IFU requirements is a planned activity within our design and development process. GP-012 Design, Redesign and Development defines Phase 5 (Product Validation) activities, which explicitly include "Labelling / User manual / Translation" as a design phase activity subject to verification and validation. The verification method statement in R-TF-001-006 (described below) implements this planned activity by defining the scope (26 LR codes from R-TF-012-037), method (content review per EN 62304 § 5.5.2), items under review (IFU version 1.1.0.0 and device label), and acceptance criteria.

Verification record. A labeling requirements verification section has been added to R-TF-001-006 IFU and Label Validation (section "Labeling requirements verification"). This section contains:

• A verification method statement citing EN 62304 § 5.5.2, which permits verification by review, inspection, or analysis. The 26 labeling requirements (LR codes) are design inputs specifying information content that must appear in the IFU and/or device label; content review is the appropriate verification method for documentation requirements.
• A verification results table with one row per labeling requirement (26 rows), documenting for each: the LR code, requirement name, location (IFU and/or Label), the specific IFU or label section where the requirement is implemented, the acceptance criterion, and the verification result (pass/fail).
• A verification summary confirming that all 26 labeling requirements passed verification against IFU version 1.1.0.0 and the device label.

This verification record satisfies EN 62304 § 5.5 (all requirements verified, by review per § 5.5.2), EN 82304-1 § 5.2 (release documentation demonstrating the product meets specified requirements), and MDR Annex II 6.1(a)(b) (description of verification activities and evidence of adequate verification).

Traceability. R-TF-012-043 Traceability Matrix has been updated with a new Part 4 ("Labeling Requirements (LR) to Verification Evidence") that traces the 26 LR codes to their verification evidence in R-TF-001-006. The coverage analysis has been updated accordingly to include labeling requirements: 26 of 26 labeling requirements have verification evidence (100% coverage).

Validation. Validation of labeling effectiveness — confirming that the IFU and label information achieves its intended purpose for users — is addressed through the summative usability evaluation (R-TF-025-007 Summative Evaluation Report), which tested IFU comprehensibility and usability with representative users per EN 62366-1. This satisfies EN 82304-1 § 5.3 (validation of the product for intended use).

Red-lined versions of R-TF-001-006 and R-TF-012-043 will be provided.

Relevant commits

• 2d16b03b2 (2026-03-01, Taig Mac Carthy): Added labeling requirements verification section to R-TF-001-006 with verification method (EN 62304 § 5.5.2 content review), 26-row verification table mapping each LR code to its implementing IFU/label section with acceptance criteria and pass/fail results, and verification summary. Updated R-TF-012-043 traceability matrix with Part 4 (Labeling Requirements to Verification Evidence) and updated coverage analysis and conclusion.
• c1ee6f639 (2026-03-01, Taig Mac Carthy): Added "Usability of Instructions for Use" section to R-TF-025-007 (Summative Evaluation Report) with IFU usability assessment methods, results per user group (ITP and HCP), and conclusion that the IFU is usable and effective for both intended user groups per IEC 62366-1 §5.9. Updated overall conclusion to reference IFU usability assessment.