Program Overview
This intensive program equips corporate professionals with the knowledge and tools to implement robust Post-Market Surveillance (PMS) and Vigilance systems as mandated by the EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746). Led by a seasoned regulatory affairs expert with 25+ years of experience, the training blends conceptual clarity, situational insights, real-world case studies, and interactive workshops. Participants will learn to draft PMS plans and reports, integrate PMCF (Post-Market Clinical Follow-up) and trend reporting, and respond effectively to serious incidents and field safety corrective actions (FSCAs). The program ensures actionable strategies to reduce regulatory risks, enhance patient safety, and safeguard corporate reputation.
Features
- Interpret MDR & IVDR requirements for PMS and Vigilance, including Annex III obligations.
- Develop compliant PMS Plans, PMS Reports, and Periodic Safety Update Reports (PSURs).
- Integrate PMCF/PMCF Studies into ongoing surveillance activities.
- Manage serious incident reporting, FSCAs, and trend analysis effectively.
Target audiences
- Regulatory Affairs Managers & Specialists
- Quality Assurance & Compliance Professionals
- Clinical Affairs and Safety Officers
- R&D and Product Lifecycle Teams
- Corporate Risk & Audit Managers
Curriculum
- 5 Sections
- 22 Lessons
- 1 Day
- PMS & Vigilance Framework4
- Situational Awareness – Regulatory Expectations5
- 2.1PMS & Vigilance obligations by device class (I–III, Class A–D IVDs)
- 2.2Role of Notified Bodies, Competent Authorities, and EUDAMED database
- 2.3Jurisdictional Differences: EU vs. FDA (MDR vs. MDR adverse event reporting)
- 2.4Case Discussion: EUDAMED reporting timelines and company readiness challenges
- 2.5Trend Reporting, Signal Detection, FSCA Triggers, CAPA linkages
- Real-World Case Insights5
- 3.1Case Study: Device recall due to underreported vigilance incidents
- 3.2Example: IVD manufacturer failing to establish PMCF plan → NB nonconformity
- 3.3Streamlining PMS via real-world evidence and digital tools
- 3.4Integration with ISO 14971 risk management and ISO 13485 QMS
- 3.5State of the Art, Data Triangulation, Real-World Evidence, Patient Registry Data
- PMS & Vigilance Workshop4
- 4.1Exercise 1: Draft a PMS Plan for a mock Class IIb device
- 4.2Exercise 2: Incident reporting simulation – responding to Competent Authority within regulatory timelines
- 4.3Exercise 3: Root cause & CAPA mapping from vigilance case data
- 4.4Rapid Response Team, Audit Trail, Traceability Matrix, Lifecycle Documentation
- Strategic Wrap-Up & Roadmap4
- 5.1Embedding PMS as a corporate culture, not a compliance checkbox
- 5.2Leveraging AI/digital platforms for signal detection and literature monitoring
- 5.3Forward-looking strategies: EUDAMED, global harmonization, and PMS maturity models
- 5.4Closing activity: Draft a 90-day PMS/Vigilance improvement roadmap for participants’ organizations
Instructor
