Post-Market Surveillance (PMS) and Vigilance Reporting for Medical Devices and Combination Products

Post-Market Surveillance (PMS) and Vigilance Reporting for Medical Devices and Combination Products are critical components of regulatory compliance, ensuring ongoing patient safety and product effectiveness after market approval.

Regulatory bodies such as the FDA, EU MDR/IVDR, and ISO 13485 require manufacturers to systematically monitor device performance, identify emerging risks, and report adverse events or safety concerns in a timely manner. This webinar will explore the regulatory framework, key PMS requirements, vigilance reporting obligations, and best practices for establishing a proactive surveillance system. Attendees will gain insights into complaint handling, trend analysis, risk management integration, and real-world case studies to enhance compliance and mitigate risks associated with post-market failures.

Why you should Attend:
Attending this webinar will provide critical insights into regulatory expectations and best practices for Post-Market Surveillance (PMS) and Vigilance Reporting, helping professionals stay compliant and proactive in managing medical device and combination product safety.

Participants will gain a comprehensive understanding of global PMS regulations, including FDA, EU MDR/IVDR, and ISO 13485, and learn how to develop an effective surveillance system that integrates risk management, complaint handling, and real-world data analysis. With real-world case studies, expert guidance, and practical strategies, this session is essential for regulatory affairs, quality assurance, and product lifecycle teams looking to minimize compliance risks, prevent costly recalls, and enhance patient safety.

Areas Covered in the Session:

• Introduction
• Welcome and Objectives of the Webinar
• Importance of PMS and Vigilance in Ensuring Patient Safety
• Regulatory Landscape Overview: FDA, EU MDR/IVDR, ISO 13485, and Global Expectations
• Understanding Post-Market Surveillance (PMS)
• Definition and Purpose of PMS
• Lifecycle Monitoring and Continuous Safety Assessment
• Proactive vs. Reactive Approaches
• Regulatory Requirements for PMS
• FDA: 21 CFR 820.198 (Complaint Handling) and 21 CFR 822 (Post-Market Surveillance)
• EU MDR/IVDR: Articles 83-86, PMS Planning, and Periodic Safety Update Reports (PSUR)
• ISO 13485: PMS and Risk-Based Approach
• Key Components of an Effective PMS System
• Data Collection: Complaints, Adverse Events, Literature, Registries
• Trend Analysis and Signal Detection
• Link to Risk Management (ISO 14971)
• Vigilance Reporting for Medical Devices and Combination Products
• Definitions: Adverse Events, Serious Incidents, Field Safety Corrective Actions (FSCAs)
• Regulatory Reporting Timelines and Thresholds
• FDA: Medical Device Reporting (MDR) - 21 CFR Part 803
• EU MDR: Serious Incidents and FSCA Reporting Requirements
• Global Variations (e.g., Health Canada, TGA, Japan PMDA)
• Vigilance in Combination Products: Challenges and Best Practices
• Drug vs. Device Reporting Requirements
• Interplay Between FDA’s CDER and CDRH
• Developing a Robust PMS and Vigilance Program
  • Best Practices for an Integrated PMS Strategy
  • Cross-Functional Collaboration (RA, QA, Clinical, Post-Market Teams)
  • Role of PMS in CAPA and Continuous Improvement
  • Post-Market Clinical Follow-Up (PMCF) and Real-World Evidence
  • Effective Complaint Handling and Risk-Based Approaches
  • Complaint Trending and Investigations
  • Linking PMS Data to Design Changes and Regulatory Submissions
  • Common Pitfalls and How to Avoid Them
• Case Studies and Industry Trends
• Real-World Examples of PMS and Vigilance Failures and Their Consequences
• Lessons Learned from Recent FDA/EU Regulatory Actions
• Trends in Digital PMS, AI-Based Signal Detection, and Automation in PMS

• Regulatory Affairs Professionals
• Quality Assurance (QA) and Compliance Teams
• Medical Device and Combination Product Manufacturers
• Post-Market Surveillance (PMS) and Vigilance Teams
• Clinical Affairs and Post-Market Clinical Follow-Up (PMCF) Teams
• Risk Management Professionals
• Product Lifecycle and R&D Teams
• Pharmacovigilance Teams (for Combination Products)
• Regulatory Consultants and Auditors
• Medical Device Distributors and Importers