Program Overview
This intensive 1-day program equips professionals with a deep understanding of the EU Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR) frameworks, blending conceptual clarity with real-world insights. Delivered by an industry veteran with 25+ years of experience, the course combines regulatory foundations, situational challenges, real-life case studies, and interactive simulations to help participants navigate approval complexities, avoid compliance pitfalls, and develop actionable strategies for EU market access. The workshop is highly practical, ensuring participants leave with knowledge and tools directly applicable to their corporate challenges.
Features
- Understand the EU MDR/IVDR landscape and its impact on medical devices.
- Identify regulatory risks and compliance bottlenecks in market access.
- Apply real-world strategies from case studies to organizational contexts.
- Build a practical roadmap for smoother EU market entry and approval.
Target audiences
- Regulatory Affairs and Quality Assurance Teams
- R&D Professionals
- Operations Teams
- Supply Chain Professionals
Curriculum
- 4 Sections
- 17 Lessons
- 1 Day
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- Understanding the EU Regulatory Landscape5
- 1.1Key regulatory bodies: European Commission, EMA, Competent Authorities, Notified Bodies
- 1.2Frameworks: Medical Device Regulation (MDR 2017/745) & In-Vitro Diagnostic Regulation (IVDR 2017/746)
- 1.3Product classification: Class I, IIa, IIb, III devices
- 1.4CE Marking process – requirements, timelines, costs
- 1.5Conformity Assessment, Clinical Evaluation, PMS (Post-Market Surveillance), Vigilance Reporting, UDI (Unique Device Identification)
- Practical Challenges & Industry Dynamics5
- 2.1Role of Notified Bodies – capacity constraints, approval delays
- 2.2Case examples of regulatory tightening after MDR implementation
- 2.3Technical documentation requirements, Clinical evaluation reports (CERs) & evidence gaps, Supply chain compliance (importers, distributors, authorized reps), Brexit impact (UKCA vs CE marking)
- 2.4Market Surveillance, EUDAMED, SSCP (Summary of Safety & Clinical Performance)
- 2.5Situational mapping: identifying “go/no-go” decisions in market access strategy
- Learning from Industry Successes & Failures4
- Hands-On Regulatory Problem-Solving3
- 4.1Exercise 1: Mapping a device’s EU market access pathway – from classification to CE marking
- 4.2Exercise 2: Identifying regulatory risks in a case dossier (incomplete clinical data, missing vigilance plan, etc.)
- 4.3Group Activity: Drafting a mini Market Access Roadmap for a hypothetical company entering EU
Instructor
