Curriculum
- 5 Sections
- 21 Lessons
- 1 Day
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- MDR Overview5
- 1.1Evolution: From MDD (93/42/EEC) to MDR (2017/745).
- 1.2Scope Expansion: Inclusion Of Software, Reprocessed Devices, Cosmetic Devices.
- 1.3Intended Purpose, Economic Operators, UDI, SSCP
- 1.4Core Pillars: Risk Classification, Conformity Assessment, Clinical Evaluation, Post-market Surveillance (Pms), Vigilance Reporting.
- 1.5Annex I (GSPR), Annex XIV (Clinical Evaluation), Annex XV (Clinical Investigations), NB audits, CE marking.
- Compliance & Market Challenges5
- 2.1Risk-based classification rules (Class I, IIa, IIb, III).
- 2.2Conformity assessment routes and notified body roles.
- 2.3Clinical evaluation & performance data expectations.
- 2.4Documentation: Technical File vs Design Dossier, CER (Clinical Evaluation Report), SSCP, PMS plan.
- 2.5Market Challenges: Notified Body Bottlenecks, Device Shortages, SME Pressures, EUDAMED Implementation Delays.
- Real-Life Case Sharing – Lessons from MDR Implementation4
- Interactive Simulation & Exercises3
- Wrap-Up & Key Takeaways4