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