Overview

The European Union Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) introduced a fundamental shift in how medical devices and diagnostic products must be evaluated, documented, monitored, and maintained across their lifecycle. These regulations place greater emphasis on clinical and performance evidence, ongoing post-market surveillance, and traceability across design, manufacturing, and field use. Unlike the previous MDD and IVDD frameworks, MDR and IVDR require manufacturers to demonstrate not only that devices are safe and effective at the time of market entry, but that they remain safe and effective through continuous performance monitoring, complaint trending, signal detection, and risk-based surveillance. This means the regulatory burden does not end at CE marking; compliance becomes a sustained, actively managed operational responsibility.

As the 2026 transition milestones approach, manufacturers face increased scrutiny from Notified Bodies and regulators, particularly around the adequacy of clinical/performance evidence, the maturity of post-market clinical follow-up (PMCF) plans, the integration of risk management into operational decision-making, and the clarity and traceability of technical documentation. Many organizations are also confronting capacity constraints among Notified Bodies, making timely submission readiness and complete documentation packages essential to avoid delays or loss of market access. Understanding these evolving expectations is critical for medical device and diagnostic companies seeking to maintain compliance, protect product availability, and demonstrate responsible lifecycle oversight in a more transparent and performance-driven regulatory environment.

Why should you Attend

This webinar is essential for medical device and diagnostic professionals who need clear, practical guidance to navigate the evolving MDR and IVDR requirements as the 2026 transition deadlines approach. Attendees will learn exactly what regulators and Notified Bodies are prioritizing right now, how to strengthen clinical and performance evidence, how to build effective post-market surveillance and PMCF plans, and how to ensure technical documentation is complete, traceable, and inspection-ready. Whether you are updating an existing device portfolio or preparing new products for CE marking, this session will provide actionable steps to avoid delays, prevent costly nonconformities, and maintain uninterrupted market access in an increasingly demanding regulatory landscape.

Areas Covered in the Session

• Brief Introduction (2-3 minutes)
  • Purpose: Clarify key regulatory changes impacting medical devices and IVDs through 2026
  • Focus is on practical compliance adjustments, not regulation recitation
• The Evolving EU Regulatory Landscape (8 minutes)
  • Transition from MDD / IVDD to MDR / IVDR - where industry is now
    
  • Extended transition timelines and the meaning of conditional "grace periods"
  • Current Notified Body (NB) capacity constraints and approval bottlenecks
  • What regulators are signaling in 2024-2026 surveillance priorities
• MDR/IVDR Requirements Driving the Greatest Impact (10 minutes)
  • Clinical Evidence and Performance Data
    • Increased rigor in clinical / performance evaluation
    • Requirements for legacy device evidence updates
  • Post-Market Surveillance (PMS) and Post-Market Clinical Follow-Up (PMCF) expectations
  • Risk Management fully integrated into lifecycle controls (ISO 14971 alignment)
  • UDI and EUDAMED database transparency and obligations
  • Technical Documentation depth and structure expectations
• Working with Notified Bodies in the Current Environment (10 minutes)
  • NB selection strategy and managing capacity limitations
  • Submission readiness standards: completeness, traceability, justification
  • Common NB feedback themes:
    • Insufficient clinical justification
    • Weak benefit-risk narrative
    • Incomplete traceability linking design inputs -outputs -verification -validation
  • How to prepare SMEs for NB interactions and Q&A rounds
• Conducting a Practical MDR/IVDR Gap Assessment (12 minutes)
  • Evaluate the state of clinical/performance evidence against current device claims
  • Confirm PMS/PMCF activities are producing actionable data, not just reports
  • Ensure risk files reflect:
    • Current field data
    • Complaint trends
    • CAPA triggers
  • Verify technical documentation is:
    • Complete
    • Navigable
    • Supported by rationale and justification language
  • Align QMS to reinforce lifecycle surveillance, not only design-stage controls
• Compliance Strategy and Implementation Roadmap (10 minutes)
  • Prioritize remediation based on risk + NB expectation + market impact
  • Strengthen clinical/performance data generation plans (registries, RWE, literature, PMCF studies)
  • Formalize a PMS/PFMEA feedback loop to demonstrate learning and prevention
  • Update labeling, IFUs, and intended use statements to match verified evidence
  • Establish internal review cycles to maintain documentation currency, not reactiveness
• Final Review (3 minutes)
  • MDR/IVDR success depends on evidence quality, traceability, and proactive surveillance
  • Continuous lifecycle oversight-not one-time remediation-is required
  • Q&A

Who Will Benefit

• Quality Assurance (QA)
  
• Quality Control (QC)
  
• Regulatory Affairs
  
• Manufacturing Operations / Production
  
• Technical Operations / MS&T
  
• Validation and Quality Engineering
  
• Supply Chain and Supplier Quality Management
  
• Laboratory Management / LIMS Administrators
  
• Clinical Quality (for organizations with GCP oversight)
  
• Documentation and Records Management
  
• Training and Competency/Qualification Teams
  
• Internal Audit / Compliance and Inspection Management Teams

Speaker Profile