Regulatory Aspects for MedTech Products, ID: EI71057

Content

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
Format Lecture
Language German/English
Dozent

Bassil Akra

Credits 5 ECTS
SWS 2 SWS
Semester SoSe
Time

Tuesday, 8:00 - 9:30 Uhr

Kick-off: 16.04.2024, 8:00 Uhr

Place Theresienstraße 90 / N3, Lecture Hall N0314 and/or Zoom
Examination