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Regulatory Status
Silvia Health is committed to transparency about the regulatory status of its products. This page provides a clear summary for clinicians, organisations, and regulators.
Silvia Lite
Silvia Lite is a structured digital intake tool for menopause consultations. It captures and organises patient-reported information for clinician review.
Silvia Lite does not diagnose, prescribe, or automate clinical decisions. All clinical judgement remains with the treating clinician.
Silvia Health does not consider Silvia Lite to meet the definition of a medical device under current UK regulations. It functions as a standardised information capture and consultation preparation tool.
The tool uses structured questions that reflect health domains relevant to menopause care, including areas covered by NICE NG23 and related guidance. These questions are for information organisation purposes and do not constitute clinical advice.
Silvia Pro
Silvia Pro is an intended future regulated product. It is currently in development.
Silvia Pro is not commercially available. It is not deployed in clinical care.
Silvia Health intends to pursue regulatory submission as a Software as a Medical Device (SaMD) through the MHRA pathway for the Pro product.
All descriptions of Silvia Pro features on this website reflect design intent only and do not represent current functionality.
Our approach to clinical safety and compliance
Silvia Health develops all products with clinical oversight and in alignment with recognised UK clinical guidance, including NICE NG23 (menopause) and NG12 (suspected cancer referral) frameworks.
Our development process includes clinical review of all content and workflows, with a focus on safety, accuracy, and transparency. We maintain clear separation between information organisation tools (Silvia Lite) and clinical decision support capabilities (Silvia Pro, in development).
For regulatory enquiries, please contact us at amy.wild@silviahealth.co.uk.