Medical Disclaimer

Effective date: 14 May 2026 · Last updated: 14 May 2026
Issued by: MB Labelis, Gedimino pr. 1, LT-01103 Vilnius, Lithuania

Important: Labelis is a clinical workflow support tool, not a medical device and not a clinical decision support system. It does not provide medical advice, diagnosis, or treatment recommendations. All clinical decisions must be made by qualified healthcare professionals.

1. Not a Medical Device

Labelis is a software application designed to support administrative and documentation workflows in healthcare and laboratory settings. It is not classified as a medical device under EU Medical Device Regulation (EU MDR 2017/745) or any other applicable regulatory framework. It has not been reviewed, cleared, or approved by any medical device regulatory authority (including the European Medicines Agency, the U.S. FDA, or equivalent bodies).

The App is intended solely as an organizational and documentation aid. It must not be used as a substitute for any approved medical device or clinical system.

2. No Medical Advice

Nothing within the Labelis App, this website, or any related materials constitutes medical advice, medical diagnosis, or a medical treatment recommendation. Information displayed by the App — including data decoded from barcodes, labels, or entered by users — is provided for informational and workflow support purposes only.

Always seek the advice of a licensed physician, nurse, or other qualified healthcare professional regarding any medical condition or treatment, and before taking any action based on information obtained through the App.

3. Professional Responsibility

Healthcare professionals who use Labelis remain fully responsible for:

All clinical decisions made in connection with patient care
Verifying the accuracy and completeness of any label or barcode data decoded by the App before acting on it
Ensuring that the App's use complies with their organization's clinical protocols and standards of care
Complying with all applicable healthcare regulations, professional standards, and institutional policies

MB Labelis accepts no responsibility for clinical outcomes resulting from reliance on information provided by the App.

4. Accuracy of Scanned Data

The App uses automated camera-based scanning and optical character recognition (OCR) to decode barcodes, QR codes, and label text. While we strive for accuracy, scanning results may be:

Incomplete or partially decoded due to label damage, poor lighting, or camera quality
Incorrectly decoded due to similar-looking characters or symbol variants
Based on outdated catalog data (e.g., GUDID or EUDAMED device databases)

Always verify decoded label data against the physical label and your organization's official records before any clinical use. Never rely solely on App output for patient identification, medication administration, or device identification.

5. No Clinical Decision Support

Labelis does not analyze patient data or scanned information to generate clinical recommendations, alerts, or risk scores. Any pattern recognition, flagging, or summary features are administrative conveniences only and must not be interpreted as clinical guidance.

6. Emergency Situations

Labelis is not designed for emergency clinical use. In any medical emergency, follow your organization's emergency procedures and contact emergency services immediately. Do not rely on the App in time-critical clinical situations.

7. Data Integrity

Patient records, photos, and label data stored in the App are only as accurate as what was entered or captured by users. MB Labelis does not verify, validate, or audit the clinical accuracy of data stored within the App. You are responsible for the integrity of data you enter.

8. Integration with External Systems

Where the App integrates with external hospital or clinic patient management systems (EMR/HIS), data transferred between systems is provided for informational purposes. Such integrations do not confer any clinical validation on the data exchanged. Healthcare professionals must verify transferred data against source systems as required by their clinical protocols.

9. Regulatory Compliance

Your organization is solely responsible for ensuring that use of Labelis within your clinical environment complies with applicable national healthcare regulations, including but not limited to:

EU Medical Device Regulation (MDR) 2017/745 and applicable IVDR provisions
National laws governing the processing of health data (including GDPR Art. 9 special category data)
Institutional policies on the use of third-party software in clinical settings

MB Labelis does not provide regulatory compliance advice. Consult qualified legal and regulatory advisors before deploying the App in regulated clinical environments.

10. Limitation of Liability

To the fullest extent permitted by applicable law, MB Labelis shall not be liable for any injury, harm, loss, or damage (including clinical harm to patients) arising from the use of or reliance upon information provided by the Labelis App. This includes, without limitation, any inaccuracies in scanned label data, patient record errors, or failure of the App to operate as expected in a clinical setting.

This Medical Disclaimer supplements and is incorporated into our Terms of Service. In the event of any conflict, the Terms of Service shall prevail.

11. Questions

If you have questions about appropriate clinical use of Labelis, contact us at:

Email: support@labelis.app
Post: MB Labelis, Gedimino pr. 1, LT-01103 Vilnius, Lithuania