Transparency matters. Here is our detailed roadmap to MHRA authorisation - timeline, costs, and standards.
Current Status: In Development
HeAIth does NOT have MHRA approval. We are an investigational clinical decision support tool in development and cannot be used for clinical care.
Expected MHRA authorisation: Q3 2026 (subject to funding and successful compliance)
What is MHRA AIaMD Classification?
HeAIth is classified as Class IIb AI as a Medical Device (AIaMD) - moderate to high risk software that provides differential diagnoses and investigation recommendations. Incorrect suggestions could lead to patient harm, requiring conformity assessment by a UK Approved Body.
The 7-Phase Regulatory Pathway
Regulatory authorisation is a 12-18 month process:
Phase 1: Foundation (Q4 2025 – Months 1-3)
- CSO and DPO appointment
- Regulatory strategy and documentation framework
- Device classification confirmation
Cost: £35,000 - £100,000
Phase 2: Quality & Safety Systems (Q1 2026 – Months 3-6)
- ISO 13485 Quality Management System
- ISO 14971 Risk Management framework
- DCB0129 Clinical Safety compliance
- Clinical Safety Case Report
Cost: £40,000 - £80,000
Phase 3: Technical Documentation (Q1 2026 – Months 6-9)
- Technical File and Clinical Evaluation Report
- Data Protection Impact Assessment
- Clinical validation studies
Cost: £30,000 - £60,000
Phase 4: Conformity Assessment (Q2 2026 – Months 9-12)
- UK Approved Body audit
- UKCA Certificate of Conformity
- MHRA device registration
Cost: £15,000 - £40,000
Phase 5: NHS Readiness (Q2 2026 – Months 10-12)
- NHS DTAC completion
- Cyber Essentials certification
- HL7 FHIR interoperability
- NHS Digital integration testing
Cost: £35,000 - £95,000
Phase 6: Market Entry (Q3 2026 – Q4 2027)
- UKCA marking and Declaration of Conformity
- Post-market surveillance system
- Limited NHS pilot (2-3 trusts)
Cost: £10,000 - £25,000
Phase 7: Product Refinement & International Expansion (2028+)
- Cost optimisation and accuracy improvements
- International regulatory preparation (EU, US)
- Scalability for multi-country deployment
Phase 8: Post-Market Surveillance (Ongoing)
- Performance monitoring and incident reporting
- Annual reviews and clinical evaluation updates
Cost: £20,000 - £50,000/year
Total Investment: £250,000 - £500,000
Full regulatory compliance requires substantial investment:
- ISO 13485 QMS: £20,000 - £50,000
- Clinical Safety Officer: £20,000 - £100,000/year
- Data Protection Officer: £15,000 - £80,000/year
- UK Approved Body Assessment: £15,000 - £40,000
- Clinical Evaluation & Validation: £10,000 - £25,000
- NHS DTAC & Interoperability: £30,000 - £80,000
- Regulatory Consulting: £20,000 - £60,000
This represents 35% of our £500k-700k seed funding round.
Key Standards & Compliance
- MHRA Regulations: UK MDR 2002, UKCA marking, AIaMD classification
- Quality Management (ISO 13485): Comprehensive QMS audited annually by UK Approved Body
- Risk Management (ISO 14971): Systematic risk analysis covering clinical, security, and AI-specific risks
- Clinical Safety (DCB0129): NHS standards requiring CSO, hazard analysis, and Clinical Safety Case Report
- NHS DTAC: Essential for NHS procurement eligibility
- Data Protection: UK GDPR compliance, DPIA, ICO registration, NHS DSPT
- Cybersecurity: Cyber Essentials certification, ISO 27001 alignment, penetration testing
- Interoperability (HL7 FHIR R4): Integration with NHS systems (EMIS, SystmOne) and SNOMED CT support
Why It Takes 12-18 Months
Healthcare startups often underestimate regulatory timelines:
- ISO 13485 implementation: 4-8 months
- Clinical validation studies: 3-6 months
- UK Approved Body review: 3-6 months
- Technical File preparation: 2-4 months
Rushing leads to failures. We have built realistic timelines with contingency.
Why Transparency Matters
Healthcare AI has a credibility problem. Companies misrepresent regulatory status and promise unrealistic timelines.
Our approach: We clearly state our development status, provide realistic timelines, and openly share our regulatory roadmap. This builds trust with advisors, investors, and future customers.
Questions?
Contact us at maximus.smith@heaith.co.uk or view our Regulatory Status Page.