Essential General Requirements for Software as a Medical Device (SaMD) Conformity Assessment

The conformity assessment process for Software as a Medical Device (SaMD) requires adherence to essential general requirements that apply across all risk classifications. This document outlines these core requirements for Class I, Class IIa/IIb, and Class III SaMD products under UK regulations, focusing on the mandatory elements manufacturers must address regardless of device classification.

Essential General Requirements for All SaMD Classifications

All SaMD products, regardless of their classification, must meet the following essential requirements as outlined in the UK Medical Devices Regulations 2002:

1. Safety and Performance

SaMD must be designed and manufactured to ensure that when used under intended conditions, it will:

• Not compromise patient clinical conditions or safety
• Present acceptable risks when weighed against benefits
• Achieve the performance intended by the manufacturer (please refer to Medical Device Claims & Intended Purpose)

Safety and performance requirements include:

1. Reducing use errors through proper ergonomic design
2. Considering the technical knowledge and capabilities of intended users
3. Eliminating or minimizing risks through inherently safe design
4. Implementing adequate protection measures for risks that cannot be eliminated
5. Informing users of any residual risks

2. Software Validation and Verification

For software-based medical devices, specific validation requirements include:

1. Software must be validated according to state-of-the-art principles
2. Development must follow established software lifecycle methodologies
3. Risk management must be integrated throughout development
4. Verification and validation must be comprehensive and documented

3. Technical Documentation Requirements

All SaMD products must maintain technical documentation covering:

1. Product description and variant information
2. Design specifications and verification data
3. Risk analysis and management file
4. Compliance evidence for essential requirements
5. Clinical evaluation documentation
6. Declaration of Conformity

Standards for Meeting Essential Requirements

The following standards are crucial for demonstrating compliance with essential requirements for all SaMD classifications:

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
• Medicines and Healthcare products Regulatory Agency. (2022). Guidance on legislation: UK Medical Devices Regulations 2002 (SI 2002 No 618, as amended). GOV.UK. https://www.gov.uk/government/publications/medical-devices-uk-regulations-guidance
• National Institute for Health Research. (2023). Software as a Medical Device (SaMD) Regulatory Pathway. NIHR HealthTech Research Centre. https://hrc-devices.nihr.ac.uk
• International Organization for Standardization. (2016). ISO 13485:2016 – Medical devices — Quality management systems — Requirements for regulatory purposes. ISO. https://www.iso.org/standard/59752.html
• International Electrotechnical Commission. (2015). IEC 62304:2006+AMD1:2015 CSV – Medical device software — Software life cycle processes. IEC. https://webstore.iec.ch/publication/22794
• Department of Health and Social Care. (2023). Guidance for manufacturers on clinical investigations. GOV.UK. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1097796/Guidance_for_mfrs_on_clinical_investigations-May_2021.pdf