Regulatory Status

Silvia is a structured menopause intake tool. It captures and organises patient-reported information before a consultation, so the clinician starts with the full picture. The questions reflect health domains relevant to menopause care, in line with NICE NG23 guidance.

Each practice or clinic sets its own rules for what is highlighted and how it is routed, alongside the guidance. Silvia applies those rules consistently.

Silvia does not diagnose, prescribe, refer or automate clinical decisions. All clinical judgement remains with the treating clinician.

Based on its intended purpose, Silvia does not meet the definition of a medical device under current UK regulations. Our clinical safety work follows NHS standard DCB0129, overseen by our named Clinical Safety Officer. If future functionality brings Silvia within the medical device definition, we will follow the appropriate MHRA route before release.

For regulatory enquiries, contact amy.wild@silviahealth.co.uk.