Medical Device Regulation (MDR)

Dear applicant, thank you for your interest in participating in the MDR Seminar. The course is currently not being offered in the WS 22/23. If you are still interested in the course in the following semesters please write the zimt-office@fau.de an email with your name, your profession (for example student) and in which semester you wanted to participate in. 

In order to introduce a medical device into the market, it is essential not only to have the technical knowledge of the production process but also the rules and regulations of the entire product life cycle. As medical devices are products that have a medical purpose and are intended for the use of humans, manufacturers have to adhere to strict legal requirements. Consequently, knowledge of this evermore complex subject matter of medical device regulation is indispensable for any successful and competitive market entry.

The Central Institute of Medical Engineering now offers the opportunity to learn more about the regulatory requirements of medical devices for the European / International markets (in an English seminar).

Please notice that the seminar “Medical Device Regulation” is taught only in English.

Course objectives

The certificate course “Medical Device Regulation” offers a combination of knowledge acquisition in a university setting and the character of a seminar with the opportunity to make contacts with participants as future specialists.

  • You will become acquainted with the German and European legislative frameworks for medical technology products.
  • You will understand the conditions, connections, and interdependencies between the corresponding directives, laws, and standards.
  • You will be enabled to take the necessary measures to comply with legal requirements successfully and in a timely manner.

Course structure

Each certificate course consists of 10 different seminar topics with tests taken separately. Attendance at all 10 seminar topics needs to take place within two years. Following successful participation, you will receive an FAU certificate. The attendance of individual seminar topics is also possible without a test. The seminar topics are composed of professional lectures and practical parts, for example, group work.

MDR Seminar topics

  • Introduction to the medical device law
  • Risk management
  • Medical Device Regulation
  • 3D-Printing in Medical Engineering
  • Artificial Intelligence
  • Other countries, other customs
  • Usability Engineering
  • Clinical Evaluation
  • Software for Medical devices
  • Medical Devices in the field
  • Quality Management

Pricing Information

Pricing Information for Professionals:

  • 8 teaching units per single seminar topic: 346,00 Euro*
  • 80 seminar topics (complete course, including examination fee): 3.300,00 Euro*
  • One time examination: 186,00 Euro*
  • Members of ZiMT, ASQF e.V. or Medical Valley EMN e.V.: 25% Discount**
  • Members of Forum MedTech Pharma e.V.: 10% Discount**

* Tax-free according to German law §4 Nr. 22a UStG
** Only one discount applies

Pricing Information for Doctoral Candidates:

  • Doctoral candidates: 70,00 Euro* pro seminar topic.
  • FAU’s Doctoral candidates: 35,00 Euro* pro seminar topic.
  • One time examination: 186,00 Euro*

* Tax-free according to German law §4 Nr. 22a UStG

Pricing Information for Students:

  • Participation in the “Medical Device Law (MPR)” course and the examination are free of charge for students enrolled at FAU in Medical Engineering.
  • For Medical Engineering students (FAU): more than 6 seminar topics: 35 Euro* per seminar topic.
  • Students of other subject-related courses enrolled at FAU: 35 euros* per seminar topic.

* Tax-free according to German law §4 Nr. 22a UStG

Pricing Information for Students:

  • Participation in the “Medical Device Law (MPR)” course and the examination are free of charge for students enrolled at FAU in Medical Engineering.
  • For Medical Engineering students (FAU): more than 6 seminar topics: 35 Euro* per seminar topic.
  • Students of other subject-related courses enrolled at FAU: 35 euros* per seminar day

* Tax-free according to German law §4 Nr. 22a UStG

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