Program Overview
This program introduces participants to the European Union Medical Device Regulation (MDR 2017/745), equipping them with the knowledge and practical skills to manage compliance challenges. Delivered by an industry veteran with over 25 years of regulatory experience, the course blends conceptual clarity, situational insights, real-world case studies, and interactive simulations. Participants will learn the differences between MDR and MDD, apply risk-based device classifications, navigate conformity assessments, and understand clinical evidence and post-market obligations. With practical exercises and expert examples, the program ensures participants leave with actionable strategies to handle regulatory risks, prepare robust documentation, and align compliance with business goals.
Features
- Interpret the EU MDR framework and its impact on device manufacturers.
- Classify devices accurately under MDR’s risk-based rules.
- Prepare compliant documentation including CER, PMS Plan, and SSCP.
- Anticipate notified body challenges and regulatory bottlenecks.
Target audiences
- Regulatory Affairs Professionals
- R&D & Compliance Teams
- Product Development Teams
- Quality Assurance & Clinical Affairs Professionals
Curriculum
- 5 Sections
- 21 Lessons
- 1 Day
- 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
Instructor
