MHRA Guidance on Ambient Voice Technology Classification

PV impact

Manufacturers and NHS organizations must evaluate their AVT products against these classification criteria. If a tool is classified as a medical device, it must comply with medical device vigilance reporting requirements, including adverse incident reporting. PV and device vigilance teams should review their portfolios of digital health tools to ensure correct classification and reporting workflows are in place.

Exact policy details

Regulatory Clarification

AVT products solely intended for transcription or summarising clinical conversations are not regulated as medical devices.

Applies to: Applicable to AVT products used in health and care settings in Great Britain.

The guidance confirms that those AVT products that are intended solely for transcription, summarising of clinical conversations, drafting letters, or suggesting clinical codes for a clinician to review are not regulated as medical devices under the current framework. · p. 1 · High · Source

Regulatory Requirements

AVT products that support diagnosis or treatment, or that take automated action without clinician review, are regulated as medical devices.

Applies to: AVT products with diagnostic or therapeutic intent.

AVT products intended to support diagnosis, treatment or prevention, or that take automated action such as placing orders without clinician review, are regulated as medical devices and must meet the relevant safety and performance requirements. · p. 1 · High · Source

Clinical Oversight Assurance

NHS boards and executive teams must assure that AVT deployment is supported by appropriate clinical oversight.

Applies to: Applicable to NHS organizations implementing AVT products.

NHS boards and executive teams are asked to assure themselves that AVT deployment is supported by appropriate clinical oversight, local governance, staff training and procurement processes. · p. 1 · High · Source

Extracted documents

• MHRA clarifies regulatory status of ambient voice technologies used in the NHShtmlhtml · high · 1 page