Self-certified Class I Medical Device Workflow Agent
What does this mean?
The Workflow Agent is a self-certified Class I Medical Device under UK MDR (Medical Device Regulations) 2002, registered with the MHRA.
This means that X-on Health has self-certified with the MHRA to classify the Workflow Agent as a Class I Medical Device. Unlike higher-risk categories, Class I Software Medical Devices do not require a Notified Body audit for market approval.
A Class I device poses minimal potential harm to patients and is typically simple in design and function. They are generally non-invasive, non-implantable, and not life-sustaining.
The Workflow Agent has been classified by X-on Health as a Class I medical device, due to NHS guidelines around the use of Generative AI for summarisation and the MHRA guidance for software as a medical device.
What is the Workflow Agent?
The Workflow Agent is intended to automate the collection, transcription, and summarisation of preliminary patient data. This allows for GPs to gather patient clinical history, symptom descriptions and administrative details from patients, for the purpose of initiating follow-up communication.
The core Medical Device Class I functionality is in how the Workflow Agent presents a summarisation of the conversation between the patient and the Voice Agent, which the practice staff member can then review. For example, within the Omni Consultations platform, users can now access the summarisation of a patient’s conversation with the Voice Agent as well as reviewing the full transcription.
The Class I self-certification is only relevant for the Workflow Agent, and not any of X-on Health’s other products.
Why does this matter?
Structured data collection
The Workflow Agent utilises text-to-speech and speech-to-text technology to gather patient information in a clear and structured format. This information is compiled into a response for practice users to triage, ensuring clinicians have actionable data before a call-back.
Reduced cognitive load
By automating patient request data gathering, the system reduces the cognitive load for clinicians, allowing them to focus on direct patient care.
Equity of access
The Workflow Agent ensures patients accessing services via telephone receive the same structured navigation and triage as those using digital text-based interfaces, such as Online Consultation request forms.
Customer testimonials
“We needed a solution where phone users had the same access and triage pathway as digitally enabled patients. The Voice Agent is as big a step forward for patient communications as telephony was in the first instance.”
– Patrick
Business & Digital Transformation Manager
Farnborough PCN
Further information
For more information around instructions for use, accreditation and more, click here
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