Conformity Assessment Routes for Software as a Medical Device (SaMD)

The regulatory approval process for Software as a Medical Device (SaMD) follows specific conformity assessment routes determined by the device’s risk classification. Understanding these pathways is essential for manufacturers seeking to bring SaMD products to market in the UK and European regulatory landscapes.

Classification-Based Assessment Routes

Medical device classification directly determines the conformity assessment route required for regulatory approval. The process varies significantly between lower-risk Class I devices and higher-risk Class IIa, IIb, and III devices.

Class I Devices

For Class I SaMD products, the conformity assessment route consists of:

1. Technical Documentation Development – Comprehensive documentation demonstrating compliance with relevant safety and performance requirements
2. Quality Management System Implementation – Documented processes ensuring consistent quality control
3. Self-certification – Manufacturer declaration of conformity without third-party intervention
4. MHRA Registration – Official registration with the Medicines and Healthcare products Regulatory Agency (MHRA)

Class IIa, IIb, and III Devices

Higher-risk devices follow a more rigorous pathway:

1. Technical Documentation Development – More extensive than Class I requirements
2. Quality Management System Implementation – Must comply with ISO 13485 standards
3. MDR Requirements Fulfillment – Adherence to Medical Device Regulation specifications
4. Assessment by Approved Body – Mandatory evaluation by a UK Conformity Assessment (UKCA) approved body
5. UKCA Certification – Obtaining the UK Conformity Assessed mark
6. MHRA Registration – Official registration in the MHRA database

References

• Medicines and Healthcare products Regulatory Agency. (2023). Medical devices: conformity assessment and the UKCA mark. GOV.UK. https://www.gov.uk/guidance/medical-devices-conformity-assessment-and-the-ukca-mark
• National Institute for Health Research. (2024). Medical device classification and conformity assessment routes. NIHR. https://www.nihr.ac.uk/explore-nihr/support/medical-device-classification.htm
• ISO. (2016). ISO 13485:2016 – Medical devices — Quality management systems — Requirements for regulatory purposes. International Organization for Standardization. https://www.iso.org/standard/59752.html
• Department of Health and Social Care. (2024). Guidance on the UK medical devices regulations. GOV.UK. https://www.gov.uk/government/publications/medical-devices-uk-regulations-guidanceRetry
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