Medical Device Regulation (MDR)

We are happy to announce that the Medical Device regulation seminar will commence again in the summer semester 2023. We will be opening registrations on 13th March – 31th March:

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 Profile Area 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) with the help of specialists from academia and also industry.

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

Contact: zimt-mdr@fau.de

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. Attendance to all 10 seminar topics needs to take place within two years. Following successful participation of all 10 seminar topics (which includes an online exam at the end of each semester) you will receive a FAU certificate. If you don’t want to take the online exams then you will just receive a confirmation of participation. The attendance of individual seminar topics is also possible.

The seminar topics are composed of professional lectures and practical parts, for example, group work.

MDR Seminar topics

  • Introduction to the medical device law (SS 23 and every following semester)
  • Risk management (SS 23 and every following semester)
  • Clinical Evaluation (SS 23)
  • Software for Medical devices (SS 23)
  • Medical Devices in the field (SS 23)
  • Quality Management (SS 23)
  • 3D-Printing in Medical Engineering (WS 23)
  • Artificial Intelligence (WS 23)
  • Other countries, other customs (WS 23)
  • Usability Engineering (WS 23)

Timetable

19.04. (kick-off in person) 8:30 – 18:00 Introduction into Medical Device Regulation 1&2

26.04. (online) 8:30 – 13:00 Risk management 1

03.05. (online) 8:30 – 13:00 Risk management 2

10.05. (online) 8:30 – 13:00 Software for Medical Devices 1

17.05. (online) 8:30 – 13:00 Software for Medical Devices 2

31.05. (online) 8:30 – 13:00 Clinical Evaluation 1

07.06. (online) 8:30 – 13:00 Clinical Evaluation 2

14.06. (online) 8:30 – 13:00 Quality Management 1

21.06. (online) 8:30 – 13:00 Quality Management 2

28.06. (online) 8:30 – 13:00 Medical Devices in the field 1

05.07. (online) 8:30 – 13:00 Medical Devices in the field 2

12.07. (online) Exam at 9:00 am

Pricing Information

General information:

10 Seminar topics for the certified course (6 topics in one semester and 4 in the other semester)

Medical Engineering Students enrolled in the FAU can do one semester with 2,5 ECTs with an Online Exam.

Each seminar has 8 teaching units (8 x 45 minutes)

The first seminar will be an in person event (19.04.23 8:30 am – 6 pm) with a Networking session after the course

Pricing Information for Professionals:

  • Fee per single seminar topic: 400,00 Euro*
  • Examination Fee per topic: 50,00 Euro*
  • 10 seminar topics (complete course, including examination fee): 3.500,00 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:

  • External doctoral candidates: 80,00 Euro* per seminar topic.
  • FAU’s Doctoral candidates: 40,00 Euro* per seminar topic.

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

Pricing Information for Students:

  • Participation in the „Medical Device Regulation“ course and the examination are free of charge for students enrolled at the FAU in the degree Medical Engineering for 6 topics (1 Semester)
  • For Medical Engineering Students (FAU), that want to take more than 6 Seminar Topics: 35 Euro* per seminar topic
  • Students of other subject-related courses enrolled at FAU: 40 Euro* per seminar topic.
  • External students: 80 Euro*

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

Registration Professionals












    • Course format:

      Discounts (please choose 1):

      Have you already participated in the MDR Seminar?

      At the end of the SS2023, are you planning to take the exam?

      Please select the dates you'd like to participate in for this SS23:
      (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 Doctoral Candidates












      • 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 SS2023, are you planning to take the exam?

        Please select the dates you'd like to participate in for this SS23:
        (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 Students












        • Student Status

          Have you already participated in the MDR Seminar?

          At the end of the SS2023, are you planning to take the exam?

          Please select the dates you'd like to participate in for this SS2023:
          (All dates can be chosen flexibly within two years)

          Registration conditions:
          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.

        Introduction to Medical Device Regulation on YouTube

        Cooperation partners: