The EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) were introduced to enhance patient safety, improve device traceability, and ensure a more robust regulatory framework for medical devices and diagnostics within the European Union. Replacing the previous Medical Device Directive (MDD) and In Vitro Diagnostic Directive (IVDD), these regulations impose stricter requirements for clinical evidence, post-market surveillance, and notified body oversight. While MDR has been in effect since 2021, the phased implementation of IVDR continues, with key deadlines extending into 2025 and beyond. Companies must navigate evolving regulatory expectations, manage compliance challenges, and adapt to ongoing updates from the European Commission and Medical Device Coordination Group (MDCG). Staying informed on these changes and proactively adjusting compliance strategies is crucial for maintaining market access and avoiding regulatory pitfalls.
The EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) continue to evolve, posing ongoing challenges for medical device and diagnostic manufacturers. With 2025 bringing critical deadlines, regulatory updates, and new compliance expectations, companies must stay ahead to ensure smooth market access and adherence to stringent requirements. This webinar will provide a comprehensive overview of the latest MDR and IVDR changes, their impact on regulatory strategies, and practical steps for achieving compliance. Attendees will gain insights into notified body expectations, post-market surveillance updates, EUDAMED implementation, and industry best practices to navigate the complex EU regulatory landscape efficiently.
The EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) continue to evolve, posing ongoing challenges for medical device and diagnostic manufacturers. With 2025 bringing critical deadlines, regulatory updates, and new compliance expectations, companies must stay ahead to ensure smooth market access and adherence to stringent requirements. This webinar will provide a comprehensive overview of the latest MDR and IVDR changes, their impact on regulatory strategies, and practical steps for achieving compliance. Attendees will gain insights into notified body expectations, post-market surveillance updates, EUDAMED implementation, and industry best practices to navigate the complex EU regulatory landscape efficiently.
Why You Should Attend
This training is essential for regulatory affairs professionals, quality assurance managers, medical device and IVD manufacturers, compliance officers, and anyone responsible for ensuring adherence to EU MDR and IVDR requirements. If you are involved in regulatory submissions, product certification, post-market surveillance, or EUDAMED compliance, this webinar will equip you with the latest updates and practical strategies to navigate evolving regulations. Whether you are working to transition legacy devices, engage with notified bodies, or streamline your compliance processes, this session will provide valuable insights, real-world examples, and actionable steps to stay ahead of 2025 regulatory challenges.Course Content
- Introduction
- Welcome and speaker introduction
- Objectives and learning outcomes of the session
- Quick overview of EU MDR and IVDR
- Scope and significance
- Key differences between MDR and IVDR
- Importance of compliance in 2025 and beyond
- Key Updates in EU MDR & IVDR for 2025
- Recent Regulatory Changes & Extensions
- Overview of new/amended regulations
- Updates from the European Commission & MDCG
- Latest deadlines and transition timelines
- Challenges in MDR/IVDR Implementation
- Notified body capacity and certification delays
- New guidance documents and evolving interpretations
- UDI (Unique Device Identification) updates
- Post-market surveillance and reporting requirements
- IVDR-Specific Changes for 2025
- Status of legacy IVD devices under extended transition periods
- Changes in classification and requirements for performance evaluation
- EUDAMED and IVDR reporting obligations
- Compliance Strategies & Best Practices
- Regulatory Readiness Checklist
- Gap analysis and impact assessment
- Steps to ensure conformity with MDR/IVDR
- Notified Body Engagement
- How to prepare for certification audits
- Best practices for technical documentation submissions
- Post-Market Surveillance (PMS) & Vigilance Reporting
- New reporting timelines and expectations
- Handling field safety corrective actions (FSCA)
- EUDAMED Implementation Strategies
- Practical steps to comply with database requirements
- Common challenges and solutions
- Digital Transformation & Automation in Compliance
- Use of digital tools for regulatory documentation
- AI and automation for tracking compliance metrics
- Case Studies & Industry Perspectives
- Real-world Challenges & Solutions
- Case studies of successful MDR/IVDR transitions
- Common pitfalls and how to avoid them
- Q&A Session (Interactive Discussion with Participants)
Speaker
Charles Paul is an instructional designer and management consultant with over 30 years experience providing training and consulting services to regulated industries. He has installed quality systems and designed and developed GMP and operational documentation and training programs for foods and beverage, pharmaceuticals, biotech, cosmetics, and consumer product OTC industries.Who Should Attend
- Regulatory Affairs Specialist
- Regulatory Affairs Manager
- Quality Assurance Specialist
- Quality Assurance Manager
- Compliance Officer
- Clinical Affairs Manager
- R&D Engineer
- Product Development Manager
- Medical Device Consultant
- Risk Management Specialist
- Post-Market Surveillance Specialist
- Notified Body Liaison
- Technical Documentation Specialist
- Design Assurance Engineer
- Manufacturing Engineer
- Supply Chain Manager
- Labeling and UDI Compliance Specialist
- EUDAMED Compliance Specialist
- Chief Compliance Officer
