Conformity Assessment Route for Class IIa SaMD

Software as a Medical Device (SaMD) that falls into the Class IIa risk category must follow a specific conformity assessment route to obtain regulatory approval for the UK market. This structured pathway ensures that all Class IIa medical software meets essential safety and performance requirements.

Overview of the Class IIa Conformity Assessment Process

Class IIa medical devices, including software, require a more rigorous assessment compared to Class I devices. The manufacturer cannot self-certify these products; instead, a UK Approved Body must assess and approve the device before it can receive UKCA marking and enter the market.

Step-by-Step Conformity Assessment Pathway

1. Classification Confirmation: Verify that your software is correctly classified as a Class IIa 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, which will review and approve your declaration if requirements are met.
7. Declaration of Conformity: Complete the formal declaration of conformity (Appendix IX) 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 IIa 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 Approved Body can perform the conformity assessment through one of four methods:

• Examination and testing of each software version
• Audit of the production quality assurance system
• Audit of final inspection and testing procedures
• Audit of the full quality assurance system

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