Regulatory Affairs

Medical device manufacturers are obliged to comply with a variety of legislations and regulatory requirements. The Medical Device Regulation (MDR) regulates the placing on the market of medical devices in Europe. In order to maximize the safety for patients, users and third parties, the General Safety and Performance Requirements (Annex I) need to be fulfilled.

The compliance with the Essential Requirements are checked from the Technical File (MDR Annex II and III). Among others, the so called Harmonized Standards support the appropriate preparation of this file. These standards represent a step-by-step instruction for the corresponding application area, e.g.:

  • EN 13485 for a quality management system
  • EN 14971 for a risk management system
  • EN 62366-1 for usability engineering
  • EN 62304 for the software life cycle
  • EN 60601-1 for electrical safety
  • and many more

We deal with the application, interpretation, auditing and impact of such legislation.
Our self-developed simulation game “Regulatory Affairs” allows our students to learn the practical application of these theoretical contents.


Prof. Dr. rer. nat. Michael Scholtes

  • Ostanlage 45
    Building B14
    Room 4.07 (4. OG)
  • +49 641 309 6653
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