This page will help you understand questions such as:
- What regulatory approvals does my innovation need to be used in the NHS?
- How is my innovation classified (medical device, digital/AI tool, or service), and why does this matter?
- What evidence, clinical safety, and data protection standards do I need to meet?
- Which national frameworks or bodies (e.g. MHRA, NICE, DTAC) apply to my innovation?
- What Net Zero and sustainability requirements must I meet for NHS adoption or procurement?
What regulatory approvals does a healthcare innovation require in the NHS?
Regulatory requirements within the NHS vary depending on the type of innovation. Select the category heading below to explore the requirements that apply to your innovation.
Medical or diagnostic devices
Requires:
- Compliance with UK Medical Device Regulations 2002 and UK Conformity Assessment (UKCA) marking
- Medicines and Healthcare products Regulatory Agency (MHRA) registration
- Alignment with NICE guidance
- Clinical safety standards
- Data protection compliance
- Net zero requirements
Digital or AI software innovations
Requires:
- Digital Technology Assessment Criteria (DTAC) framework
- NICE evidence standards framework for digital health technologies
- Clinical safety standards
- Data protection compliance
- ISO/IEC 42001 compliance for AI technologies
- Net zero requirements
Note: If a digital innovation qualifies as a medical device, it must also comply with all applicable medical device regulatory requirements.
Services, care pathways, or non-technology innovations
Requires:
- Clinical safety standards
- Alignment with NICE guidance
- Data protection compliance
- Net zero requirements
Overall, understanding and meeting key regulatory and compliance requirements is essential for the successful adoption of any innovation within the NHS. These requirements vary depending on the type of innovation, but consistently include considerations around clinical safety, evidence standards, data protection, and alignment with national frameworks. Innovators must also ensure their solutions meet sustainability and Net Zero expectations to support NHS procurement and long-term implementation.