How do you handle post-market surveillance and reporting?

Post-market surveillance (PMS) and reporting are critical components of maintaining compliance with global regulatory requirements and ensuring the safety and efficacy of medical devices once they are on the market. Below is an overview of the process:

1. Establishing a Post-Market Surveillance System

• Develop a Post-Market Surveillance Plan as part of your Quality Management System (QMS) in compliance with:
  • FDA 21 CFR Part 820 (Quality System Regulation).
  • EU MDR (Regulation 2017/745), Article 83.
  • ISO 13485:2016 requirements.
• The plan outlines methods for data collection, analysis, and corrective actions tailored to the specific device.

2. Data Collection

• Gather information from various sources, including:
  • Customer Feedback: Complaints, reviews, or product inquiries.
  • Clinical Data: Post-market clinical follow-up (PMCF) studies, if applicable.
  • Adverse Event Reports: Direct reports from healthcare professionals or users.
  • Device Registries and Public Databases: Such as the FDA’s MAUDE (Manufacturer and User Facility Device Experience) database.
  • Internal Sources: Manufacturing data, quality audits, and service reports.

3. Risk Assessment and Analysis

• Evaluate the collected data to:
  • Identify any trends, patterns, or increases in adverse events.
  • Determine whether risks associated with the device are still acceptable under ISO 14971 (Risk Management for Medical Devices).
  • Investigate complaints and incidents to assess root causes.

4. Adverse Event Reporting

• Comply with regulatory reporting requirements for adverse events:
  • FDA Medical Device Reporting (MDR):
    • Submit reports for events where the device may have caused or contributed to serious injury, death, or malfunctions that could lead to harm.
    • Report timelines: Usually within 30 days; expedited reports for serious threats (5 days).
  • EU Vigilance System:
    • Report serious incidents and field safety corrective actions (FSCA) to the appropriate Competent Authority.
  • Other Jurisdictions (e.g., MDSAP):
    • Follow local adverse event reporting timelines and criteria.

5. Field Safety Corrective Actions (FSCA)

• Implement actions when necessary, such as:
  • Device recalls or market withdrawals.
  • Design or labeling modifications.
  • Issuing Field Safety Notices (FSNs) to users and healthcare providers.
• Ensure FSCA is coordinated with regulatory authorities.

6. Periodic Reporting

• Prepare regular updates or reports as required by regulations:
  • FDA: Maintain records of complaints and adverse events; periodic inspections ensure compliance.
  • EU MDR:
    • Class I Devices: Annual updates to the PMS report.
    • Class IIa, IIb, III Devices: Submit a Periodic Safety Update Report (PSUR) summarizing PMS data and risk-benefit evaluations.

7. Corrective and Preventive Actions (CAPA)

• Investigate non-conformities identified through PMS.
• Implement corrective actions to resolve issues and preventive actions to mitigate future risks.