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Regulatory Status
Silvia Health is committed to transparency about the regulatory status of its platform. This page provides a clear summary for clinicians, organisations, and regulators.
Silvia
Silvia is a structured digital intake platform for menopause consultations. It captures and organises patient-reported information for clinician review.
Silvia does not diagnose, prescribe, or automate clinical decisions. All clinical judgement remains with the treating clinician.
Silvia is preparing for registration as a Class I medical device with the MHRA — a step we are taking voluntarily, ahead of any regulatory requirement to do so, because we believe clinicians and patients deserve that level of scrutiny and trust in a platform used in clinical care.
The platform 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.
Our approach to clinical safety and compliance
Silvia Health develops the platform 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. Silvia is built to support clinical judgement — not replace it. Every output is patient-reported information, structured for clinician review. That is not a temporary limitation; it is a design principle that won't change as the platform evolves.
For regulatory enquiries, please contact us at amy.wild@silviahealth.co.uk.
Silvia is designed to support clinical judgement — not replace it. It captures and organises patient-reported information across 18 clinical domains for clinician review. It does not diagnose, prescribe, or automate clinical decisions. Silvia is preparing for registration as a Class I medical device with the MHRA.