Conformity Assessment Route for Class IIb SaMD

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

Overview of the Class IIb Conformity Assessment Process

Class IIb medical devices, including software, are generally regarded as medium to high risk and require thorough assessment by an Approved Body before they can receive UKCA marking and enter the market. The conformity assessment process is more stringent than for lower-risk classifications.

Step-by-Step Conformity Assessment Pathway

1. Classification Confirmation: Verify that your software is correctly classified as a Class IIb medical device according to Part II UK MDR 2002 Annex IX. View Annex IX classification rules
2. Essential Requirements Verification: Ensure your product meets all applicable essential requirements as detailed in Part II UK MDR 2002 Annex I. View Annex I essential requirements
3. Clinical Evaluation: Conduct a thorough clinical evaluation following the guidelines in Part II UK MDR Annex II to demonstrate safety and performance.
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 IIb devices, this can follow one of two routes:
   • Audit of full quality assurance system, 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
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.
10. Post-Market Surveillance: Implement and maintain ongoing post-market surveillance and corrective procedures.

Technical Documentation Requirements

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

• Essential requirements
• Comprehensive technical documentation
• Declaration of conformity
• Risk management file detailing risk assessment, analysis plans, and mitigation processes

Assessment Options

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

1. Audit of full quality assurance system
   • Comprehensive review of the manufacturer’s quality management system
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.

References

1. Medicines and Healthcare products Regulatory Agency. (2002). UK Medical Devices Regulations 2002. https://www.legislation.gov.uk/uksi/2002/618/contents/made
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