R-TF-001-007 EU Declaration of Conformity
AI Labs Group, SL (hereinafter referred to as "us" or "we"), located at Gran Vía 1, BAT Tower, 48001 Bilbao, Bizkaia, Spain, hereby certify under our responsibility that the manufactured product and its version:
Legit.Health (version 2.1)
Complies with the applicable regulations:
- UNE-EN ISO 13485:2016 Quality management systems. Requirements for regulatory purposes.
- UNE-EN 62304:2007/CORR:2009/A1:2016 Medical device software. Software life cycle processes.
- UNE-EN ISO 14971:2019 Medical devices/health products. Application of risk management to MD.
- UNE-EN ISO 15223-1: 2017 Health products. Symbols to be used on labels, labelling and information to be supplied.
- UNE-EN 1041: 2009/A1:2014 Information provided by the manufacturer of medical devices.
- UNE-EN 62366:2009/A1:2015 Application of usability engineering to medical devices.
And complies with the provisions of Council Directive 93/42/EEC for Medical Devices and issued exclusively under our responsibility.
Class I (Rule 12)
All documentation supporting this CE Declaration of Conformity is preserved in the document management system of the manufacturer.
This document was issued in Bilbao, on the following date:
| Approved by |
|---|
E-Signature (Appfire integration):  Andy Aguilar 9F11050EA2ED0539F5F305B8C8B68296 Signer name: Andy Aguilar Signing time: Mon, 12 Oct 2020 12:00:00 GMT Reason: New version approval |
| JD-001 General Manager |
There have been no significant changes in the design or intended use of the product as set out in the MDCG 2020-3 Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD. We have issued a new document due to the update of the company's registered office.
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