Response

We acknowledge that corrective action 4 was insufficiently implemented. The User Interface section of the IFU included a sample label that did not demonstrate all applicable GSPR 23.2 items, and did not include a requirement for installers to provide users with access to the eIFU. The IFU has been updated to address both gaps. Red-lined documentation is provided.

a. The sample label in IFU, § User Interface has been updated to include all applicable GSPR 23.2 items. The following items were missing and have now been added:

• 23.2(a): Device name or trade name: added the device name as explicit text.
• 23.2(b): Intended purpose: added a brief intended purpose statement identifying the device.
• 23.2(h): UDI carrier: added the UDI symbol (ISO 15223-1) and UDI string in HRI format.
• 23.2(j): Date of manufacture: added the manufacture date symbol (ISO 15223-1) and date field.
• 23.2(m): Warnings or precautions: added warning text alongside the caution symbol (previously icon-only).
• 23.2(q): "Medical device" indication: added the MD symbol (ISO 15223-1) with text.

Items 23.2(c) (manufacturer name and address), 23.2(g) (version/batch number), CE marking, and the "consult instructions for use" symbol were already present and have been retained.

In addition to the updated sample label, the IFU now includes an explicit table enumerating which GSPR 23.2 items are applicable to this software medical device and what must be displayed for each, so that installers have a clear specification rather than a general instruction.

Items 23.2(d), (e), (f), (i), (k), (l), (n), (o), (p), (r), and (s) are not applicable to this software medical device (these concern authorised representatives for non-EU manufacturers, medicinal substances, tissues/cells, time limits for safe use, storage conditions, sterility, single use, reprocessing, custom-made devices, substances via body orifice/skin, and implantable serial numbers, respectively).

We note that the full regulatory label, which already included all applicable GSPR 23.2 items, is specified in IFU, § General Information > Label. The device's JSON output also includes complete label data in machine-readable format. The update ensures that the User Interface section (installation instructions for integrators) now demonstrates the same completeness.

b. The IFU, § User Interface now includes a new subsection titled "Access to the Electronic Instructions for Use (eIFU)" that:

1. States a mandatory requirement for installers to ensure clinical users (healthcare professionals) can access the eIFU.
2. Provides the canonical eIFU URL: https://ifu-eu-mdr.legit.health/.
3. Lists acceptable methods for providing eIFU access: displaying the URL in the user interface (e.g., label area, help menu, or "about" screen), including it in user onboarding or training materials, or communicating it via email at account provisioning.
4. References the regulatory basis: Regulation (EU) 2021/2226 (conditions for electronic IFU provision pursuant to MDR 2017/745, GSPR 23.1(f)).
5. Notes that the eIFU URL is also embedded in the device's JSON output (eIFU field) and displayed in the label alongside the "consult instructions for use" symbol.
6. Cross-references the existing IFU section "Request Paper IFU," which describes the paper IFU request process in accordance with Regulation (EU) 2021/2226, Article 5.

BSI observation: GSPR 17.1 reference: The reference to "Annex I, Article 17.1" in the opening paragraph of IFU, § User Interface was a drafting error inherited from corrective action 4. The original corrective action plan referenced "Annex I, 17.2" (software development lifecycle); during implementation this was changed to "17.1" (repeatability, reliability, and performance of electronic programmable systems). Neither is correct for this section, which concerns the information supplied with the device. The reference has been corrected to Annex I, Chapter III of the MDR 2017/745 (Requirements regarding the information supplied with the device), which is the correct regulatory basis for the User Interface section's content (label, eIFU, and installation instructions for integrators).

Note: eIFU URL update: Our documentation previously used https://apidocs-draft.legit.health/ as a placeholder eIFU URL, since the IFU should not be published at its final location before certification. As this has been a source of confusion during review, we have now replaced all references with the canonical IFU location: https://ifu-eu-mdr.legit.health/. This URL is now used consistently across the IFU (User Interface section, label, and JSON output) and all related documentation. However, keep in mind that opening said URL will not display the IFU until certification is achieved and the IFU is published at that location.

Relevant commits

• af47e84 (2026-03-01, Taig Mac Carthy): Expanded IFU apps/eu-ifu-mdr/versioned_docs/version-1.1.0.0/installation-manual/user-interface.mdx with GSPR 23.2 requirements table, updated sample label with all applicable items (23.2(a), (b), (h), (j), (m), (q)), and added "Access to the Electronic Instructions for Use (eIFU)" subsection.
• 687add72 (2026-03-01, Taig Mac Carthy): Post-review corrections. Removed over-sharing from IFU user-interface.mdx. Updated General-Safety-and-Performance-Requirements-GSPR.mdx to correct the Annex I reference from 17.1 to Chapter III. Added eIFU URL to R-TF-001-006-IFU-and-Label-Validation.mdx.