Slide 1: Understanding the Shift: EU MDR 2017/745. Slide 2: From Directives to Regulation. Slide 3: Key Objectives of the MDR. Slide 4: Timeline and Entry into Force. Slide 5: Overall Regulatory Framework Shift. Slide 6: Expanded Scope: What's In?. Slide 7: Expanded Scope: Examples. Slide 8: Changes to Risk Classification Rules. Slide 9: Impact of Classification Changes. Slide 10: General Safety and Performance Requirements (GSPR). Slide 11: GSPR - Emphasis on Risk Management. Slide 12: Technical Documentation - The Foundation. Slide 13: Technical Documentation - Increased Detail Required. Slide 14: Clinical Evidence - The Core Requirement. Slide 15: Clinical Evaluation Process. Slide 16: Clinical Evaluation Reports (CERs). Slide 17: Post-Market Clinical Follow-up (PMCF). Slide 18: Post-Market Surveillance (PMS) System. Slide 19: Vigilance System Enhancements. Slide 20: Traceability - The UDI System. Slide 21: UDI - Implementation and Requirements. Slide 22: EUDAMED Database - The Central Hub. Slide 23: EUDAMED - Key Modules and Functionality. Slide 24: Notified Bodies - Enhanced Role and Oversight. Slide 25: Notified Bodies - Designation and Monitoring. Slide 26: Person Responsible for Regulatory Compliance (PRRC). Slide 27: Economic Operators - Defined Responsibilities. Slide 28: Increased Transparency and Public Access. Slide 29: Specific Device Types - Software (SaMD). Slide 30: Specific Device Types - Reprocessed SUDs. Slide 31: Transitional Provisions. Slide 32: Impact on Manufacturers. Slide 33: Impact on Notified Bodies. Slide 34: Impact on Healthcare Professionals & Patients. Slide 35: Key Challenges in Implementation. Slide 36: Market Surveillance by Competent Authorities. Slide 37: Summary of Key Changes. Slide 38: Navigating the MDR Landscape. Slide 39: The Goal: Safer Devices for Patients. Slide 40: Stay Informed and Prepared. Slide 41: Thank You