BSI Request — Marketing Material, Website and IFU Corrections
Communication Reference
| Field | Value |
|---|---|
| Subject | Follow-up to BSI management call — 23 March 2026 |
| BSI Request Date | April 2026 |
| BSI Contact | Risk and Compliance Team, BSI |
| Legit Health Contact | Saray Ugidos, Quality and Regulatory Affairs Manager |
| Response Date | 27 April 2026 |
| Related QMS Procedures | GP-001 (Control of documents), GP-023 (Change control management) |
Background
During a call held on 23 March 2026 between AI Labs Group S.L. (Legit Health) and BSI's management team, BSI identified that certain public-facing communications on the Legit Health website and in IFU documentation contained inaccurate statements regarding the device's conformity assessment status.
Specifically, certain website content incorrectly described the device as "Certified as a Class IIb medical device under the EU Medical Device Regulation (MDR 2017/745)", when in fact:
- The device currently holds a Class I self-declaration under the EU Medical Device Directive (MDD 93/42/EEC), valid through 2028.
- The MDR Class IIb conformity assessment is in progress with BSI as the Notified Body but has not yet been completed or certified.
Additionally, the EU IFU MDR (draft version v1.1.0.0) — which is part of the ongoing MDR Class IIb submission — was inadvertently accessible via the IFU link on the public website, when only the current MDD IFU should have been publicly available.
BSI Requested Actions
BSI's Risk and Compliance team requested the following priority actions:
- Review and correct all public-facing communications to ensure strict alignment with the device conformity assessment status.
- Remove or amend any statements implying the device is already certified as Class IIb under the EU Medical Device Regulation (MDR 2017/745).
- Provide evidence to BSI that the above corrections have been completed.
Actions Taken
All corrective actions were completed on 20 March 2026 — prior to the receipt of the formal written request from BSI — following an internal review triggered by the 23 March 2026 call preparation. The corrections were implemented by Taig Mac Carthy (Co-Founder & CEO) and verified by the quality team.
Action 1 — Regulatory Status Claims Corrected Across All Public-Facing Content
Commit: e6a3ced66 — "Fix typo in regulatory status claims across website" — 20 March 2026
Scope: 21 files across all 4 website locales (EN, ES, DE, FR), including press releases, the public health system page, blog content, and SEO structured data.
Changes made:
| Location | Before (Incorrect) | After (Correct) |
|---|---|---|
| Public health system page | "Certified as a Class IIb medical device under the EU Medical Device Regulation (MDR 2017/745)" | "Currently transitioning to Class IIb under the EU Medical Device Regulation (MDR 2017/745), with the certification process under review by our Notified Body (BSI)" |
| Public health system page | "This dual certification, particularly the higher-risk Class IIb designation..." | "This regulatory pathway, particularly the pursuit of the higher-risk Class IIb designation under MDR..." |
| Public health system page | Tip box stating "The formal publication of the MDR Class IIb certificate is pending..." | Removed entirely |
| SEO structured data | "CE Mark Class IIb Medical Device" | "CE Mark Medical Device (MDD)" |
| Press releases (EN, ES, DE, FR) | Various references implying Class IIb certification | Corrected to reflect current MDD Class I status |
| Website structured data | Class IIb reference | Corrected to MDD |
Action 2 — Unsubstantiated Performance Claims and Diagnostic Language Removed
Commit: 82b66349f — "Remove unsubstantiated performance claims and diagnostic language from website" — 20 March 2026
Scope: 95 files across all 4 website locales (EN, ES, DE, FR), including blog posts, press releases, homepage, footer, and i18n configuration files.
Changes made:
| Category | Before (Incorrect) | After (Correct) |
|---|---|---|
| Performance numbers | Specific accuracy percentages (93.23%, 94%, etc.) | Removed — not appropriate for promotional material |
| Diagnostic language | "diagnoses/detects [conditions]" | "supports the clinical assessment of" |
| Condition count | "232 skin conditions" | "a wide range of skin conditions" |
| Promotional language | "revolutionary" | "advanced" |
| Unsubstantiated claims | "clinically proven" | "supported by published clinical evidence" |
| Patient empowerment claims | "triples the empowerment" | "enhances the autonomy" |
| Homepage tagline & footer | Updated across all locales | Aligned with CDSS intended purpose |
Action 3 — Promotional Language Aligned with CDSS Intended Purpose
Commit: 777353f26 — "Align promotional content language with CDSS intended purpose across website" — 20 March 2026
Scope: 11 files — specific blog posts and pages where language needed further refinement to use precise clinical decision support terminology.
Changes made:
- Replaced absolute comparative claims with specific, evidence-based descriptions
- Harmonised language across EN/ES/DE/FR locales
- Ensured all public-facing content accurately reflects the device's intended purpose as a Clinical Decision Support System (CDSS)
Action 4 — IFU Link Corrected
The public website IFU link (https://apidocs.legit.health/) now serves exclusively the MDD IFU (Class I), which is the currently valid Instructions for Use for the device on the market. The draft EU IFU MDR (v1.1.0.0) is no longer publicly accessible and is maintained internally within the QMS as part of the ongoing MDR Class IIb submission to BSI.
Current State — Evidence of Compliance
Website (https://legit.health/)
| Page / Element | Current Content | Status |
|---|---|---|
| Homepage | No Class IIb claims. CE Mark logo references MDD. | ✅ |
| About page | "medical device with European CE marking" — no class or regulation specified beyond CE marking and ISO 13485 | ✅ |
| Canfield comparison | "certified as a medical device" — refers to ISO 13485 compliance, no Class IIb or MDR claims | ✅ |
| Public health system page | "Certified as a Class I medical device under MDD 93/42/EEC, with certification valid through 2028" + "Currently transitioning to Class IIb under MDR" | ✅ |
| SEO structured data | "CE Mark Medical Device (MDD)" | ✅ |
| Footer (all locales) | CDSS-appropriate language, no Class IIb claims | ✅ |
| Blog posts (all locales) | Performance claims removed, diagnostic language replaced with CDSS terminology | ✅ |
| Press releases (all locales) | Regulatory status corrected across EN, ES, DE, FR | ✅ |
IFU (https://apidocs.legit.health/)
| Element | Current Content | Status |
|---|---|---|
| Device label | "Risk Classification according to Council Directive 93/42/EEC (MDD): Class I" | ✅ |
| CE marking reference | "CE marking per Council Directive 93/42/EEC" | ✅ |
| UDI | (01)8437025550005(10)2.1(11)YYYYMMDD | ✅ |
| EMDN coding | Z12040192 | ✅ |
| GMDN coding | 65975 | ✅ |
| No MDR/Class IIb references | Confirmed — no references to MDR 2017/745 or Class IIb | ✅ |
EU IFU MDR (draft v1.1.0.0)
| Element | Status |
|---|---|
| Public accessibility | ❌ Not publicly accessible — removed from public website link |
| Internal QMS location | Maintained within the version-controlled QMS (Git repository) |
| Purpose | Part of the ongoing MDR Class IIb conformity assessment submission to BSI |
Git Audit Trail
All corrections are fully traceable in the Git version control system:
| Commit Hash | Date | Author | Description |
|---|---|---|---|
e6a3ced66 | 20 March 2026 00:43 | Taig Mac Carthy | Fix typo in regulatory status claims across website (21 files) |
82b66349f | 20 March 2026 02:01 | Taig Mac Carthy | Remove unsubstantiated performance claims and diagnostic language (95 files) |
777353f26 | 20 March 2026 12:35 | Taig Mac Carthy | Align promotional content language with CDSS intended purpose (11 files) |
Preventive Measures
To prevent recurrence of inaccurate public-facing claims:
-
Marketing content review process: All public-facing content related to the device's regulatory status, classification, or performance claims must be reviewed and approved by the Quality Manager (JD-004) before publication, in accordance with GP-001 (Control of documents).
-
Regulatory language guidelines: A set of approved regulatory statements has been established for use by marketing and communications personnel. Any deviation from these approved statements requires prior written approval from the Quality Manager.
-
Periodic website audit: The quality team will conduct a quarterly review of all public-facing website content to verify alignment with the current conformity assessment status. This review will be documented as part of the quality planning process (GP-002).
Conclusion
All three actions requested by BSI have been completed:
- ✅ All public-facing communications have been reviewed and corrected to ensure strict alignment with the device's current conformity assessment status (Class I under MDD 93/42/EEC).
- ✅ All statements implying the device is already certified as Class IIb under MDR 2017/745 have been removed or amended to accurately reflect the transitional status.
- ✅ This document, together with the Git audit trail, constitutes the evidence that the corrections have been completed.
Prepared by: Saray Ugidos, Quality and Regulatory Affairs Manager, AI Labs Group S.L.
Date: 27 April 2026