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

Monday, 8:00 - 12:30 Uhr

Block1: 27.04.2026
Block2: 04.05.2026
Block3: 15.05.2026
Block4: 08.06.2026
Block5: 19.06.2026