Any product innovation in the medical device sector requires implementation of a risk-based approach to show compliance to the applicable requirements in a conformity assessment process. The European Medical Device Regulation (MDR) replaces the directives and guidelines for all medical devices. The lecture introduces the new MDR and highlights topics such as

• History of the legislative framework in the EU
• Introduction to the Medical Device Regulation
• Risk Classification of medical devices
• General Safety and Performance Requirements
• Risk Management Principles
  Structure of Technical Documentation
• Principles of Clinical Evaluation and Investigation
  Post-Market Surveillance Requirement