Regulatory status
Regulatory status
Notes-Hub and our referral processing tools are intended to support the administrative task of documenting a clinical encounter. They produce draft records and letters for a clinician to review, edit and approve. These products are not medical devices.
Last reviewed
Our position
Notes-Hub and our referral processing tools are intended to support the administrative task of documenting a clinical encounter. They produce draft records and letters for a clinician to review, edit and approve. They do not suggest diagnoses, recommend treatment, or determine follow-up. The clinician remains responsible for all clinical decisions and for reviewing and approving all output. These products are not medical devices. We monitor MHRA guidance and will reassess this position if functionality changes.
Last reviewed .
Why we publish this
The MHRA determines whether software is a regulated medical device partly from the manufacturer's stated intended purpose. That makes our own description of what our products do part of the regulatory record, not marketing.
Because intended purpose is what the regulator reads, we hold our product copy to the same standard as our documentation. We describe what the software does to the record, and we do not describe it as doing anything to the clinical decision. A single loose phrase in marketing copy can change a product’s regulatory classification, so we check for those phrases mechanically on every build.
Position by product
- Notes-Hub
- Not a medical device. Documents the clinical encounter and produces a draft note for the clinician to review, edit and approve.
- Referral processing
- Not a medical device. Structures information already recorded by the clinician into a draft letter for review and approval.
- SafeDeploy
- Not a medical device. SafeDeploy supports clinical risk management documentation. It is used by a Clinical Safety Officer, not in the care of a patient.
- Oral Health Info
- Not a medical device. General patient education. It is not personalised advice and does not relate to an individual patient's care.
- UK responsible person / manufacturer
- [PLACEHOLDER: confirm whether any MHRA registration applies, or state none]
Questions about our regulatory position?
If you are an information governance lead or a Clinical Safety Officer assessing our products, ask us directly. A registered clinician will answer.