EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) Training Webinar: Explore Impact on Regulatory Strategies, and Practical Steps for Achieving Compliance

Dublin, Nov. 05, 2025 (GLOBE NEWSWIRE) -- The "EU MDR and IVDR: Key Updates and Compliance Strategies for 2025 (Aug 6, 2025)" training has been added to ResearchAndMarkets.com's offering.

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.

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.

Who Should Attend:

Regulatory Affairs SpecialistRegulatory Affairs ManagerQuality Assurance SpecialistQuality Assurance ManagerCompliance OfficerClinical Affairs ManagerR&D EngineerProduct Development ManagerMedical Device ConsultantRisk Management SpecialistPost-Market Surveillance SpecialistNotified Body LiaisonTechnical Documentation SpecialistDesign Assurance EngineerManufacturing EngineerSupply Chain ManagerLabeling and UDI Compliance SpecialistEUDAMED Compliance SpecialistChief Compliance Officer

Key Topics Covered:

IntroductionWelcome and speaker introductionObjectives and learning outcomes of the sessionQuick overview of EU MDR and IVDRScope and significanceKey differences between MDR and IVDRImportance of compliance in 2025 and beyondKey Updates in EU MDR & IVDR for 2025Recent Regulatory Changes & ExtensionsOverview of new/amended regulationsUpdates from the European Commission & MDCGLatest deadlines and transition timelinesChallenges in MDR/IVDR ImplementationNotified body capacity and certification delaysNew guidance documents and evolving interpretationsUDI (Unique Device Identification) updatesPost-market surveillance and reporting requirementsIVDR-Specific Changes for 2025Status of legacy IVD devices under extended transition periodsChanges in classification and requirements for performance evaluationEUDAMED and IVDR reporting obligationsCompliance Strategies & Best PracticesRegulatory Readiness ChecklistGap analysis and impact assessmentSteps to ensure conformity with MDR/IVDRNotified Body EngagementHow to prepare for certification auditsBest practices for technical documentation submissionsPost-Market Surveillance (PMS) & Vigilance ReportingNew reporting timelines and expectationsHandling field safety corrective actions (FSCA)EUDAMED Implementation StrategiesPractical steps to comply with database requirementsCommon challenges and solutionsDigital Transformation & Automation in ComplianceUse of digital tools for regulatory documentationAI and automation for tracking compliance metricsCase Studies & Industry PerspectivesReal-world Challenges & SolutionsCase studies of successful MDR/IVDR transitionsCommon pitfalls and how to avoid themQ&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.

For more information about this training visit https://www.researchandmarkets.com/r/36gyhr

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