Medical Device Regulation (MDR)

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 and that during the upcoming summer semester 2022, it’s taking place via zoom.

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.

Seminar topics and dates for Summer Semester/22

Exact dates: tbd

The Seminar “Medical Device Regulation” (MDR) is going to be online.
NOTE: If you are a registered participant of the course, you are going to receive the Zoom’s or Microsoft Team’s Link via e-mail a few days before the day of the seminar.

  • “Introduction to the medical device law – Part 1”, Wednesday 27 April 2022, 8:30 a.m. to 12:30 p.m.
    Dr. Maria Henke & Christian Sauter
  • “Introduction to the medical device law – Part 2”, Wednesday 11 May 2022, 8:30 a.m. to 12:30 p.m.
    Dr. Maria Henke & Christian Sauter
  • “Risk management – Part 1”, Thursday 12 May 2022, 8:30 a.m. to 12:30 p.m.
    Christian Sauter
  • “Risk management – Part 2”, Wednesday 18 May 2022, 8:30 a.m. to 12:30 p.m.
    Christian Sauter
  • “Medical Device Regulation – Part 1”, Wednesday 25 May 2022, 8:30 a.m. to 12:30 p.m.
    Stefan Bolleininger
  • “Medical Device Regulation – Part 2”, Wednesday 01 June 2022, 8:30 a.m. to 12:30 p.m.
    Stefan Bolleininger
  • 3D-Printing in Medical Engineering, Wednesday 22 June 2022, 8:30 a.m. to 12:30 p.m.
    Sebastian Gümpelein
  • “Artificial Intelligence”, Wednesday 29 June 2022, 8:30 a.m. to 12:30 p.m.
    Tobias Schreiegg
  • “Other countries, other customs – Part 1”, Wednesday 06 July 2022, 8:30 a.m. to 12:30 p.m.
    Volker Glahn
  • “Other countries, other customs – Part 2”, Wednesday 13 July 2022, 8:30 a.m. to 12:30 p.m.
    Volker Glahn
  • “Usability Engineering– Part 1”, Wednesday 20 July 2022, 9:00 a.m. to 13:00 p.m.
    Michael Engler
  • “Usability Engineering– Part 2”, Wednesday 27 July 2022, 9:00 a.m. to 13:00 p.m.
    Michael Engler

Seminar topics for winter semester:

  • Introduction to the Medical Device Law
  • Risk Management in Medical 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

Registration for professionals

Registration form for professionals

Please register at least one week before the seminar day you’d like to participate.
We’ll confirm your participation by e-mail.
Please notice that the number of participants is limited.






    Course format:

    Discounts (please choose 1):

    Have you already participated in the MDR Seminar?

    At the end of the SS2022, are you planning to take the exam?

    Please select the dates you'd like to participate in for this SS22:
    (All dates can be chosen flexibly within two years)

    Registration conditions:
    Please consider that the number of participants is limited.
    One week in advance, cancellations are free of charge. Otherwise, the entire participation fee has to be paid.
    If something happens and the organizer has to cancel the seminar, the participation fees will be reimbursed. A claim for compensation for any cancellation or rebooking fees for transport or accommodation costs booked by the participant is not included.

    Registration for doctoral candidates

    Registration form for doctoral candidates

    Please register at least one week before the seminar day you’d like to participate.
    We’ll confirm your participation by e-mail.
    Please notice that the number of participants is limited.






      Course format:

      Discounts (please choose 1):

      To confirm your registration as a Doctoral Candidate, please send us your certificate of enrollment to zimt-mdr@fau.de

      Have you already participated in the MDR Seminar?

      At the end of the SS2022, are you planning to take the exam?

      Please select the dates you'd like to participate in for this SS22:
      (All dates can be chosen flexibly within two years)

      Registration conditions:
      Please consider that the number of participants is limited.
      One week in advance, cancellations are free of charge. Otherwise, the entire participation fee has to be paid.
      If something happens and the organizer has to cancel the seminar, the participation fees will be reimbursed. A claim for compensation for any cancellation or rebooking fees for transport or accommodation costs booked by the participant is not included.

      Registration for students

      • Registration period SS22:
        04th April – 17th April 2022
      • Participants’ Confirmation (via mail):
        20th – 22nd April 2022

      Cooperation partners: