OpenDentist NotesRegulatory Compliance
OpenDentist maintains compliance with UK healthcare regulatory frameworks, clinical safety standards, and data protection legislation.
MHRA Class I Medical Device
GMDN Code 44106 (Patient health record information system application software)
OpenDentist is registered as a Class I medical device with the Medicines and Healthcare products Regulatory Agency (MHRA), with a signed Declaration of Conformity.
ICO Registration
Registration Number: ZC020081
Registered with the Information Commissioner's Office under the UK Data Protection Act 2018 and UK GDPR.
NHS Data Security and Protection Toolkit (DSPT)
The NHS DSPT demonstrates that OpenDentist meets the National Data Guardian's ten data security standards required for organisations processing NHS data.
DCB0129 Clinical Risk Management (Manufacturer)
Clinical Safety Case Report approved by a qualified Clinical Safety Officer
Full compliance with DCB0129 including a Clinical Risk Management Plan (CRMP), Hazard Log, and Clinical Safety Case Report (CSCR), all approved by a qualified Clinical Safety Officer.
DCB0160 Clinical Risk Management (Deployer)
Deployment guidance provided to NHS organisations
Deployment documentation and clinical safety guidance provided to support NHS organisations in meeting their DCB0160 obligations when deploying OpenDentist.
DTAC Self-Assessment
Version 2.0
The Digital Technology Assessment Criteria (DTAC) self-assessment covers clinical safety, data protection, technical security, interoperability, and usability.
UK GDPR / Data Protection Act 2018
ICO registered | DPIA completed | Full documentation suite
Comprehensive data protection framework including Data Protection Impact Assessment, Records of Processing Activities, privacy notices, and documented data subject rights procedures.
Clinical Safety
Clinical Safety Officer
Davinderjit Singh, BDS PgDip Rest&Aes (GDC registered)
Qualified via NHS Digital Clinical Safety training (Intermediate level).
Hazard Analysis
13 clinical hazards identified and assessed through Functional Failure Analysis.
0
Unacceptable / High
13
Mitigated to Low or Below
Mandatory Clinician Review
All AI-generated clinical notes are drafts that require review, editing, and approval by the treating clinician before incorporation into the patient record. The system does not diagnose, recommend treatment, or make clinical decisions.