R-TF-001-007 EU Declaration of Conformity
This document is a draft version pending final certification by BSI.
Declaration
We, AI Labs Group SL, with registered office at Gran Vía 1, BAT Tower, 48001, Bilbao, Bizkaia, Spain, declare under our sole responsibility that the medical device described below complies with the applicable requirements of Regulation (EU) 2017/745 (Medical Device Regulation).
Device Identification
| Information | |
|---|---|
| Device name | Legit.Health Plus (hereinafter, the device) |
| Version | 1.1.0.0 |
| Basic UDI-DI | 8437025550LegitCADx6X |
| GMDN code | 65975 (Computer assisted diagnosis software) |
| EMDN code | Z12040192 (General medicine diagnosis and monitoring instruments - Medical device software) |
Manufacturer Information
Manufacturer:
- Legal name: AI Labs Group SL
- Address: Gran Vía 1, BAT Tower, 48001, Bilbao, Bizkaia, Spain
- Single Registration Number (SRN): ES-MF-000025345
- Website: www.legit.health
Authorized Representative: Not applicable (manufacturer established within the European Union)
Classification and Applicable Regulations
Classification: Class IIb (Rule 11 - MDR 2017/745 Annex VIII)
Justification: Software intended to provide information which is used to take decisions with diagnostic purposes. The decisions have an impact that may cause a serious deterioration of a person's state of health or influence treatment decisions, therefore it is classified as Class IIb according to Rule 11 of MDR 2017/745 Annex VIII.
Regulation: Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (Medical Device Regulation - MDR)
Conformity Assessment Procedure
Route: Annex IX - Quality assurance based on full quality assurance and examination of the design documentation
The conformity assessment procedure includes:
- Annex IX, Part I: Assessment and approval of the quality management system
- Annex IX, Part III: Assessment of the technical documentation (design dossier)
Notified Body:
- Name: BSI Group The Netherlands B.V. (British Standards Institution)
- Identification Number: 2797
- Certificate Number: MDR 792790
- Certificate Issue Date: [Pending]
- Certificate Valid Until: [Pending]
Applied Harmonised Standards and Common Specifications
The device complies with the following harmonised standards:
- EN ISO 13485:2016 - Medical devices - Quality management systems - Requirements for regulatory purposes
- EN 62304:2006/A1:2015 - Medical device software - Software life-cycle processes
- EN ISO 14971:2019 - Medical devices - Application of risk management to medical devices
- EN ISO 15223-1:2021 - Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
- EN ISO 20417:2021 - Medical devices - Information to be supplied by the manufacturer
- EN 62366-1:2015/A1:2020 - Medical devices - Part 1: Application of usability engineering to medical devices
- EN ISO 14155:2020 - Clinical investigation of medical devices for human subjects - Good clinical practice
- EN ISO 81001-1:2021 - Health software and health IT systems safety, effectiveness and security - Part 1: Safety, effectiveness and security in the design and development of health software
- EN ISO 82304-1:2016 - Health software - Part 1: General requirements for product safety
Common Specifications: No common specifications are applicable to this device.
General Safety and Performance Requirements (GSPR)
The device complies with all applicable General Safety and Performance Requirements set out in Annex I of Regulation (EU) 2017/745.
Clinical Evaluation
Clinical evaluation has been performed in accordance with MDR 2017/745 Annex XIV and MDCG 2020-13 guidance. The clinical evaluation demonstrates that the device meets the applicable General Safety and Performance Requirements and that the benefit-risk ratio is acceptable.
Technical Documentation
The complete technical documentation required by MDR 2017/745 Annex II and Annex III has been compiled and is maintained by the manufacturer. The technical documentation has been assessed by the Notified Body BSI (2797) as part of the conformity assessment procedure under Annex IX.
Declaration Statement
This EU Declaration of Conformity is issued under the sole responsibility of AI Labs Group SL.
The object of the declaration described above is in conformity with Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices.
All supporting documentation is preserved in the manufacturer's quality management system and is available for inspection by competent authorities.
Place and Date of Issue
Place: Bilbao, Spain
Date: [To be completed upon certification]
Signature
Signed for and on behalf of AI Labs Group SL:
Signature |
|---|
| Andy Aguilar |
| General Manager |
| AI Labs Group SL |
Record signature meaning
- Author: JD-004 María Diez
- Review: JD-005 Alfonso Medela
- Approval: JD-001 Andy Aguilar