Key Workflow Agent information
Device name: Workflow Agent
GMDN® Code: 44102 – Patient-administration information system application software.
MHRA Reference Number: 38536 (PARD Registration Link)
Type: Software as a Medical Device (SaMD) Class I, under UK MDR 2002 .
Intended use statement: The Workflow Agent is intended to automate the collection, transcription, and summarisation of preliminary patient consultation data. It is intended for use by General Practice (GP) Surgeries to gather patient clinical history, symptom descriptions, and administrative details from patients for the purpose of initiating follow-up communication.
Product variants: The Class I classification is only relevant for the Workflow Agent. As such, there are no product or device variants.
Instructions for Use
Please see the PDF below for the Instructions for Use for the X-on Health Workflow Agent, created as part of X-on Health’s Medical Device Class I technical file.
Workflow Agent UDI (Unique Device Identifier)
A Unique Device Identification (UDI) is a global regulatory framework that assigns a distinct, standardised numeric or alphanumeric code to medical devices. It ensures the unambiguous tracking of devices from manufacturing through distribution and patient use, significantly enhancing patient safety and supply chain management.
The X-on Health UDI label and barcode is available below.
UDI-DI Reference
UDI-DI: 5056932800008
UDI-PI: (01)5056932800008(11)260730(8012)06.2026
Disclaimers, warnings, precautions, and contraindications
⚠️Disclaimers: The device does not provide clinical diagnoses, recommend treatments, or make triage decisions. The device is strictly a data-collection and summarisation tool.
⚠️Warnings: The device utilises AI for the summarisation of the patient provided information and conversation with the Workflow Agent. Summarisation errors or misinterpretations may occur therefore; the user must review all summarisation outputs before making any clinical decisions based on them.
⚠️Precautions: The device is not intended for use in medical emergencies. It incorporates specific logic to warn patients that the system is for non-urgent issues and points them to emergency services (999/111) if required.
⚠️Contraindications: The device is explicitly not for emergency use. It is contraindicated for any patient experiencing symptoms requiring immediate medical attention. The system logic includes a specific warning step to exclude these patients, directing them instead to A&E or 999. But if they still chose to use the Workflow Agent, despite the warning in place, they will not receive or be escalated to any emergency services.
While not listed as a strict medical contraindication, the device’s reliance on voice interaction creates functional contraindications for unclear speech, where patients that may be unable to do so may fail to complete the Workflow Agent process.
Post-market surveillance
We have also added a “Thumbs Up/Thumbs Down” in-product feedback mechanism, with accompanying “add comment” box for further context. This is to support X-on Health’s post-market surveillance commitments of the Workflow Agent.
Related accreditations and standards
- Cyber Essentials and Cyber Essentials Plus
- ISO 27001
- ISO 22301
- ISO 9001
- ISO 14001
- ISO 42001
- NHSE DSPT: “Standards Exceeded” (Registration number: 8JM42).
- NHS DTAC ready.
- New! Alongside our Medical Device Class I, we can now confirm that we conform to ISO 14971 (Application of risk management to medical devices).
