Our regulatory status & data protection commitments
Important Notice
Nefra is a decision-support tool that provides estimated nutritional information. It is not a substitute for professional medical advice, diagnosis, or treatment. Always verify dietary decisions with your nephrologist or renal dietitian.
Nefra is designed to meet EU MDR 2017/745 Class IIa requirements for decision-support software. Clinical validation is in planning — CE marking will be pursued once pilot data is available.
Nefra's development follows a Quality Management System aligned with ISO 13485:2016 and IEC 62304:2006+A1:2015 for medical device software lifecycle processes.
All personal health data is processed in accordance with GDPR (EU 2016/679). Data is encrypted at rest and in transit. Users can export or delete their data at any time via the app settings.
Health records can be exported in HL7 FHIR R4 format with SNOMED CT and LOINC coding, enabling integration with electronic health record systems worldwide.
A Clinical Safety Case Report and Hazard Log are maintained as part of our clinical risk management process, addressing patient safety risks associated with AI-driven nutrient estimation.
Product: Nefra Health — AI-assisted CKD nutrition tracker
Intended users: Adult patients (≥18 years) with diagnosed Chronic Kidney Disease (stages 1–5, including dialysis) and their caregivers.
Purpose: To assist users in logging daily food intake, estimating nutrient content (potassium, phosphorus, sodium, protein, fluid, calories), and comparing intake against personalised clinical limits set in consultation with their healthcare team.
Contraindications: Not intended for acute clinical decision-making, parenteral nutrition management, or paediatric patients. Not designed for use as a sole diagnostic tool.
For questions about Nefra's regulatory status, clinical safety, or data protection practices, contact:
© 2026 Nefra Health Ltd. All rights reserved.
Nefra is a decision-support tool. Always consult your healthcare provider before making dietary changes.