Conformity Assessment Route for Class III SaMD

Software as a Medical Device (SaMD) classified as Class III represents the highest risk category and follows the most stringent conformity assessment route to obtain regulatory approval for the UK market. This document outlines the structured pathway required for Class III SaMD to receive UKCA marking.

Overview of the Class III Conformity Assessment Process

Class III medical devices, including software, are generally regarded as high risk and require thorough assessment by an Approved Body before they can receive UKCA marking and enter the market. The conformity assessment process for Class III devices is the most rigorous of all device classifications.

Step-by-Step Conformity Assessment Pathway

1. Classification Confirmation: Verify that your software is correctly classified as a Class III medical device according to Part II UK MDR 2002 Annex IX (Schedule 4) of the regulations.
   • UK Medical Devices Regulations 2002 – Main Contents
2. Essential Requirements Verification: Ensure your product meets all applicable essential requirements as detailed in Part II UK MDR 2002 Annex I (Schedule 1).
   • Access via UK Medical Devices Regulations 2002
3. Clinical Evaluation: Conduct a thorough clinical evaluation following the guidelines in Part II UK MDR Annex X (Schedule 5) to demonstrate safety and performance.
   • Access via UK Medical Devices Regulations 2002
   • Guidance: Clinical Investigations
4. MHRA Notification: Notify the Medicines and Healthcare Products Regulatory Agency (MHRA) of your clinical investigation proposal to obtain a Letter of No Objection (LONO).
5. Technical Documentation Preparation: Compile comprehensive technical documentation for your SaMD.
6. Conformity Assessment: Submit to a formal assessment by an Approved Body to approve your declaration. For Class III devices, this can follow one of two routes:
   • Audit of full quality assurance system including a design dossier examination, OR
   • Type-examination combined with one of the following:
     • Examination/testing of each product/version number
     • Audit of production quality assurance system
     • Audit of final inspection and testing
   • Guidance: Conformity Assessment and UKCA Mark
7. Declaration of Conformity: Complete the formal declaration of conformity once approved.
8. UKCA Marking: Apply the UKCA mark to your product after receiving approval.
9. MHRA Registration: Register your SaMD with the MHRA.
   • Guidance: Register Medical Devices with MHRA
10. Post-Market Surveillance: Implement and maintain ongoing post-market surveillance and corrective procedures.
    • Guidance: Implementation of Future Regulations

Technical Documentation Requirements

Manufacturers of Class III SaMD must prepare a detailed technical file that includes:

• The essential requirements detailed in Annex I (Schedule 1)
• Technical documentation (Annex II)
• Declaration of conformity (Appendix IX)
• A risk management file to assess risk and outline the risk analysis plan and processes according to ISO 14971:2019

Assessment Options

The conformity assessment for Class III devices offers two main routes:

1. Audit of full quality assurance system including a design dossier examination
   • Comprehensive review of the manufacturer’s quality management system
   • Detailed examination of the product design documentation
2. Type-examination plus one of the following:
   • Examination/testing of each product/version number
   • Audit of production quality assurance system
   • Audit of final inspection and testing

Any other applicable legal frameworks must also be addressed. After the Approved Body approves the declaration of conformity, the UKCA marking can be applied to the SaMD, allowing it to be legally placed on the UK market.

Software-Specific Considerations

Class III SaMD has additional considerations that must be addressed:

• Software validation according to the state of the art
• Cybersecurity and data protection measures
• Interoperability requirements
• User interface design and usability engineering

For detailed guidance on software-specific requirements:

• Guidance: Software and AI as Medical Devices

Key Considerations for Class III SaMD

Class III devices typically require:

• More extensive clinical evidence
• Thorough design dossier examination
• Detailed post-market clinical follow-up plans
• More frequent surveillance audits

References

1. Medicines and Healthcare products Regulatory Agency. (2002). UK Medical Devices Regulations 2002. https://www.legislation.gov.uk/uksi/2002/618/contents
2. National Institute for Health and Care Research. (2023). Software as a Medical Device (SaMD) Regulatory Pathway.
3. Department of Health and Social Care. (2022). Guidance on medical devices: conformity assessment and the UKCA mark. https://www.gov.uk/guidance/medical-devices-conformity-assessment-and-the-ukca-mark
4. MHRA. (2021). Guidance for manufacturers on clinical investigations. https://www.gov.uk/government/publications/clinical-investigations-of-medical-devices
5. International Organization for Standardization. (2019). ISO 14971:2019 Medical devices — Application of risk management to medical devices. https://www.iso.org/standard/72704.html
6. MHRA. (2023). Guidance on software and apps as medical devices. https://www.gov.uk/government/publications/medical-devices-software-and-apps
7. MHRA. (2023). Register medical devices to place on the market. https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market
8. Department of Health and Social Care. (2023). Implementation of the future regulation of medical devices. https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices/implementation-of-the-future-regulations