R-TF-001-006 IFU and Label Validation - Legacy MDD Device
- Governed by
GP-001 Document and Records Control
This record was created on 2026-03-08 as part of the corrective action for BSI Surveillance Audit 2026 (NCR 5 - Finding Reference: 2780856-202603-N5). The validation was performed retroactively to formally document the verification of IFU and Label for the Legacy MDD Class I device against the approved technical documentation.
Medical device
| Product information | |
|---|---|
| Product or trade name | Legit.Health |
| Product version | 2.1 |
| EUDAMED ID | D-Legit.Health8U |
| SRN | ES-MF-000025345 |
| Reference/Catalogue | Legit.Health |
| Class | Class I (Rule 12) per MDD 93/42/EEC |
| Regulatory framework | Council Directive 93/42/EEC (MDD) |
| Declaration | R-001-002 Manufacturer declaration of conformity (signed by Andy Aguilar, 2023-03-07) |
Label validation
The label validation has been performed in accordance with Council Directive 93/42/EEC (MDD), Annex I, Section 13 requirements for labelling of medical devices.
The label for the Legacy MDD device is published at: https://apidocs.legit.health/
| Requirement | Validation | Notes |
|---|---|---|
| The name or trade name of the device. | ✅ | "Legit.Health" - Displayed in the label |
| The name or trade name and address of the manufacturer. | ✅ | AI Labs Group SL, Gran Vía 1, BAT Tower, 48001 Bilbao, Bizkaia, Spain |
| The details strictly necessary to identify the device and the contents of the packaging. | ✅ | Software device - no physical packaging. Version and identification provided. |
| The lot number or the serial number of the device. | ✅ | Version 2.1 serves as identification for this software device |
| The UDI code. | N/A | UDI-DI not required for self-declared MDD Class I devices placed on market before 26 May 2021 |
| The special storage and/or handling conditions. | ✅ | Cloud-based software - no special storage conditions apply |
| Any special operating instructions. | ✅ | Refer to IFU for operating instructions |
| Any warnings and/or precautions to take. | ✅ | Included in IFU - device for diagnostic support only, not for standalone diagnosis |
| Manufacture date. | ✅ | Initial release 2020, current version 2023 |
| If the intended purpose of the device is not obvious to the user, it must be clearly stated. | ✅ | Intended purpose clearly stated: support HCPs in assessment of skin structures |
| An indication that the device is a medical device. | ✅ | CE marking displayed with Class I indication per MDD 93/42/EEC |
Label evidence
The label is accessible at https://apidocs.legit.health/ and includes:
- CE marking for Class I medical device under MDD 93/42/EEC
- Manufacturer identification
- Product name and version
- Intended purpose statement
- Reference to Instructions for Use
IFU validation
The validation of the Instructions for Use was performed in accordance with Council Directive 93/42/EEC (MDD), Annex I, Section 13 and the essential requirements applicable to Class I medical devices.
The IFU for the Legacy MDD device is published at: https://apidocs.legit.health/
| Requirement | Validation | Notes |
|---|---|---|
| The name or trade name of the device. | ✅ | "Legit.Health" - Displayed throughout the IFU |
| The name or trade name and address of the manufacturer. | ✅ | AI Labs Group SL, Gran Vía 1, BAT Tower, 48001 Bilbao, Bizkaia, Spain |
| The details strictly necessary to identify the device and the contents of the packaging especially for the users. | ✅ | Software identification, version, and technical specifications provided |
| The special storage and/or handling conditions. | ✅ | Cloud-based software - no special storage conditions |
| Any special operating instructions. | ✅ | API integration instructions, authentication, and usage guidelines provided |
| Any warnings and/or precautions to take. | ✅ | Warnings about diagnostic support nature, professional use only, contraindications |
| Device's intended purpose with a clear specification of indications, contra-indications, targeted patients and intended users. | ✅ | Intended purpose: support HCPs in assessment of skin structures; intended users: HCPs |
| The classification of the device according to the applicable standards. | ✅ | Class I per MDD 93/42/EEC, Rule 12 |
| Warning for any undesirable side effects. | ✅ | Not applicable - software device with no direct patient contact |
| All information needed to verify whether the device can operate correctly and safely, with details of the nature and frequency of the maintenance to ensure safety and performance. | ✅ | Technical requirements, system compatibility, and maintenance information provided |
| Information regarding the risks of reciprocal interference posed by the presence of the device during specific treatment. | N/A | Not applicable - standalone software with no interaction with treatment devices |
| Any contra-indications or precautions to be taken for the device safety use and performance. | ✅ | Contraindications and precautions documented in IFU |
| Date of issue of the instructions for use. | ✅ | Version history with dates maintained in the IFU |
| A notice to the user and/or patient that any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent national authority. | ✅ | Incident reporting instructions provided with manufacturer contact: support@legit.health |
Verification against EUDAMED registration
The following verification was performed to ensure consistency between the published IFU/Label and the EUDAMED registration:
| EUDAMED Field | EUDAMED Value | IFU/Label Value | Match |
|---|---|---|---|
| EUDAMED ID code | D-Legit.Health8U | D-Legit.Health8U | ✅ |
| SRN | ES-MF-000025345 | ES-MF-000025345 | ✅ |
| Name/Trade name | Legit.Health | Legit.Health | ✅ |
| Reference/Catalogue number | Legit.Health | Legit.Health | ✅ |
| Manufacturer name | AI Labs Group SL | AI Labs Group SL | ✅ |
| Device classification | Class I (MDD 93/42/EEC) | Class I (MDD 93/42/EEC) | ✅ |
Verification against Declaration of Conformity
The published IFU and Label information was verified against the Declaration of Conformity (R-001-002):
| Declaration Field | Declaration Value | IFU/Label Value | Match |
|---|---|---|---|
| Product name | Legit.Health | Legit.Health | ✅ |
| Product version | 2.1 | 2.1 | ✅ |
| Classification | Class I (Rule 12) | Class I (Rule 12) | ✅ |
| Regulatory framework | Council Directive 93/42/EEC | Council Directive 93/42/EEC | ✅ |
| Manufacturer | AI Labs Group SL, Gran Vía 1, BAT Tower, 48001 Bilbao | AI Labs Group SL, Gran Vía 1, BAT Tower, 48001 Bilbao | ✅ |
Conclusion
The IFU and Label for the Legacy MDD device (Legit.Health version 2.1) have been verified and validated against:
- The requirements of Council Directive 93/42/EEC (MDD), Annex I, Section 13
- The EUDAMED registration (ES-MF-000025345, D-Legit.Health8U)
- The Declaration of Conformity (R-001-002)
All required elements are present and consistent across all documentation sources.
Validation performed by
| Field | Value |
|---|---|
| Validated by | Saray Ugidos Seman |
| Position | Regulatory Affairs Manager |
| Validation date | 2026-03-08 |
| Validation method | Document review and cross-reference verification |
Signature meaning
The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:
- Author: Team members involved
- Reviewer: JD-003 Design & Development Manager, JD-004 Quality Manager & Person Responsible for Regulatory Compliance (PRRC)
- Approver: JD-001 General Manager