Program Overview
This 1-day program provides a comprehensive exploration of the EU Medical Device Regulation (MDR 2017/745) and the In Vitro Diagnostic Regulation (IVDR 2017/746). Led by an industry expert with 25+ years of experience, the workshop blends conceptual understanding, situational awareness, real-world case studies, and interactive exercises. Participants will learn about device/IVD classification, CE marking, notified body interactions, technical documentation, and post-market obligations. The course highlights regional nuances, transition challenges, and compliance pitfalls, equipping corporate teams with actionable strategies and checklists to navigate the EU regulatory landscape effectively.
Features
- Understand the EU MDR & IVDR frameworks, device classification, and CE marking pathways.
- Identify regional compliance nuances and pitfalls impacting market access.
- Apply insights from case studies of MDR/IVDR successes and failures.
- Build a practical compliance roadmap for smooth EU regulatory transition.
Target audiences
- Regulatory executives
- Quality leads
- R&D managers
- Operations leads
- Supply planners
- Compliance officers
- Market specialists
- Product managers
Curriculum
- 4 Sections
- 19 Lessons
- 1 Day
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- Regulatory Landscape & Core Concepts5
- 1.1MDR (2017/745) vs IVDR (2017/746): Scope & key differences
- 1.2Device & IVD classification rules (Class I–III, A–D for IVDs)
- 1.3CE Marking requirements & conformity assessment routes
- 1.4Role of Notified Bodies, Competent Authorities, EUDAMED
- 1.5UDI, SSCP, PSUR, PMPF (Post-Market Performance Follow-up), Vigilance, Clinical Evidence, Performance Evaluation
- Regional Nuances & Compliance Realities6
- 2.1Transition challenges: MDD/IVDD to MDR/IVDR
- 2.2Capacity constraints with Notified Bodies & approval delays
- 2.3Technical Documentation & Clinical/Performance Evaluation requirements
- 2.4Supply chain obligations, importer/distributor roles, Brexit impact
- 2.5Post-market obligations: PMS, vigilance, trend reporting
- 2.6SSCP, PMS Plan, Clinical Evaluation Report (CER), PMCF, Summary of Safety & Performance (SSP), EUDAMED Modules
- Lessons from Industry Practice5
- 3.1Case Study 1: Smooth MDR transition for a Class IIb device
- 3.2Case Study 2: IVD manufacturer facing delays due to insufficient performance evaluation data
- 3.3Case Study 3: Product recall due to post-market surveillance non-compliance
- 3.4What went wrong? What could have been done differently?
- 3.5Corporate strategies to overcome bottlenecks
- Hands-On Compliance Mapping3
Instructor
