SaMD Post-Market Surveillance

Post-market surveillance (PMS) represents a critical phase in the lifecycle of medical devices, including Software as a Medical Device (SaMD). This systematic process of monitoring device performance after market placement helps ensure ongoing safety and effectiveness while facilitating continuous improvement.

Regulatory Requirements

In the UK, post-market surveillance is not merely recommended—it is a legal requirement. Manufacturers must establish and maintain a comprehensive PMS system before their medical device receives UKCA marking and enters the market.

Key Components of PMS

A compliant post-market surveillance system includes:

1. A documented PMS plan that outlines specific activities, methodologies, and responsibilities
2. Data collection mechanisms to gather information from various sources
3. Systematic analysis procedures to evaluate collected data
4. Reporting protocols for incidents and adverse events
5. Processes for implementing corrective actions when necessary
6. Documentation systems to maintain records of all PMS activities

Data Collection Methods

Effective post-market surveillance relies on diverse data sources:

• User feedback through direct reporting and surveys
• Complaint monitoring from customers and patients
• Service and maintenance records
• Literature reviews of scientific publications
• Registry data where available
• Real-world performance monitoring
• Social media and online forums (with appropriate validation)
• Results from post-market clinical follow-up studies

For SaMD specifically, additional sources may include:

• Software performance metrics
• Usage analytics
• Error reports and crash logs
• Version update impacts
• Cybersecurity incident data

Medical Device Vigilance System

A critical component of post-market surveillance is the medical device vigilance system, which focuses specifically on identifying and addressing serious adverse events. In the UK, manufacturers must:

1. Designate a qualified person responsible for vigilance reporting
2. Implement processes to identify reportable events
3. Report serious adverse events to the MHRA within specified timeframes:
   • Serious public health threats: Immediately (no later than 2 calendar days)
   • Death or serious deterioration: 10 calendar days
   • Other reportable incidents: 30 calendar days
4. Conduct thorough investigations of reported incidents
5. Implement appropriate Field Safety Corrective Actions (FSCAs) when necessary
6. Issue Field Safety Notices (FSNs) to inform users about safety issues

Field Safety Corrective Actions

When surveillance data identifies a potential safety issue, manufacturers must:

1. Assess the risk to determine appropriate response
2. Develop and implement corrective actions
3. Verify the effectiveness of these actions
4. Notify the MHRA and affected users through Field Safety Notices
5. Document all aspects of the FSCA process

Periodic Safety Update Reports

For higher-risk devices (Class IIa, IIb, and III), manufacturers must prepare periodic safety update reports that summarize:

• Results of post-market surveillance data analysis
• Conclusions regarding benefit-risk profile
• Main findings from post-market clinical follow-up
• Sales volume and user population estimates
• Actions taken in response to identified issues

SaMD-Specific Considerations

Software as a Medical Device presents unique post-market surveillance challenges:

1. Rapid iteration: More frequent updates require robust change management
2. Remote deployment: Enables faster corrective actions but requires validated processes
3. Data collection capabilities: SaMD can often collect performance data automatically
4. Cybersecurity vulnerabilities: Require ongoing monitoring and rapid response
5. User interface issues: May emerge only through broader real-world use

Benefits of Effective PMS

A well-designed post-market surveillance system provides:

• Early detection of potential safety issues
• Evidence to support product improvements
• Data for expanding intended uses
• Input for next-generation product development
• Regulatory compliance and reduced liability
• Enhanced user trust and market reputation

Integration with Quality Management System

Post-market surveillance should not operate in isolation but rather as an integrated component of the overall quality management system (QMS). This ensures that:

• PMS findings inform risk management processes
• Corrective actions are properly validated
• Design changes incorporate real-world feedback
• Clinical evaluation is continuously updated
• Regulatory documentation remains current

References

1. Medicines and Healthcare products Regulatory Agency. (2023). Post-market surveillance (PMS), vigilance and market surveillance. https://www.gov.uk/government/publications/post-market-surveillance-pms-vigilance-and-market-surveillance
2. National Institute for Health and Care Research. (2023). Software as a Medical Device (SaMD) Regulatory Pathway. NIHR HealthTech Research Centre in Devices, Digital and Robotics.
3. British Standards Institution. (2021). BS EN ISO 13485:2016 Medical devices. Quality management systems. Requirements for regulatory purposes. https://www.bsigroup.com/en-GB/medical-devices/our-services/iso-13485/
4. Mantra Systems. (2023). Post Market Surveillance (PMS). https://www.mantrasystems.co.uk/eu-mdr-compliance/post-market-surveillance-pms
5. International Medical Device Regulators Forum. (2022). Post-Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form. http://www.imdrf.org/documents/documents.asp

For the most current guidance on post-market surveillance requirements, visit the MHRA website or consult with a regulatory specialist familiar with UK medical device regulations.