Medical Device Regulation

We are happy to announce that the Medical Device regulation seminar will commence again in the winter semester 2024.

The registration for Winter 2024 is closed.

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 the increasingly complex subject matter of Medical Device Regulation is indispensable for any successful and competitive market entry.

The Profile Center Medical Engineering (FAU MT) 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 industry.

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

Contact: faumt-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 at all 10 seminar topics needs to take place within two years. Following successful participation, you will receive a 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.

  • Introduction to the Medical Device Regulation (SS)
  • Risk management (SS)
  • Clinical evaluation (SS )
  • Software for medical devices (SS)
  • Medical devices in the field (SS)
  • Quality management (SS)
  • Introduction to the Medical Device Regulation (WS)
  • Risk management (WS)
  • 3D-Printing in medical engineering & Artificial intelligence (WS)
  • Other countries, other customs (WS)
  • Usability engineering (WS)
  • Systematic MDR-Compliant Medical Product Development (WS)

  • 28.10.24 – Introduction to the Medical Device Regulation (in-person)

  • 04.11.24 – 8:30 – 12:30 Risk management I (online)

  • 11.11.24 – 8:30 – 12:30 Risk management II (online)

  • 13.11.24 – 8:30 – 12:30 3D-Printing in medical engineering (online)
  • 27.11.24 – 8:30 – 12:30 Artificial intelligence (online)

  • 04.12.24 – 8:30 – 12:30 Other countries, other customs I (online)

  • 11.12.24 – 8:30 – 12:30 Other countries, other customs II (online)

  • 14.01.25 – 8:30 – 12:30 Systematic MDR-Compliant Medical Product Development I (online)

  • 16.01.25 – 8:30 – 12:30 Systematic MDR-Compliant Medical Product Development II (online)

  • 15.01.25 – 8:30 – 12:30 Usability engineering I (online)

  • 22.01.25 – 8:30 – 12:30 Usability engineering II (online)

General information:

There are 10 seminar topics for the certificate course (6 topics in one semester and 4 in the other semester).

Medical Engineering students enrolled at FAU can do one semester with 2.5 ECTS with an online exam (6 topics). Further 4 topics in subsequent semesters will not be considered to earn any ECTS towards your respective degree, although a participation certificate can be provided.

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

The first seminar will be an in-person event (April 26, 2024 8:30 am – 5 pm) with a networking session after the course.

Pricing Information for Professionals:

  • Fee per single seminar topic: 400 euros*
  • Examination fee per topic: 50 euros*
  • 10 seminar topics (complete course, including examination fee): 3,500 euros*
  • Members of FAU MT or Medical Valley EMN e.V.: 25% Discount** for professionals only
  • Members of Forum MedTech Pharma e.V.: 10% Discount** for professionals only

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

Pricing Information for Doctoral Candidates:

  • External doctoral candidates: 80 euros* per seminar topic.
  • FAU’s doctoral candidates: 40 euros* 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 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 euros* per seminar topic. These topics cannot be considered to earn any credits towards your respective degree.
  • Students of other subject-related courses enrolled at FAU: 40 euros* per seminar topic.
  • External students: 80 euros* per seminar topic.

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

Registration is closed.

    Course format:

    Discounts (please choose 1):

    Have you already participated in the MDR Seminar?

    At the end of the WS2024-25, are you planning to take the exam?

    Please select the dates you'd like to participate in for this WS2024-25:

    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 closed.

      Course format:

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

      Have you already participated in the MDR Seminar?

      At the end of the WS2024-25, are you planning to take the exam?

      Please select the dates you'd like to participate in for this WS2024-25:

      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 closed. Please only register if you will attend the seminar. Registrations will be processed on a first come – first served basis. Registration results, including the waiting list, will be sent by the second week of October.

        Student Status

        Have you already participated in the MDR Seminar?

        At the end of the WS2024-25, are you planning to take the exam?

        Please select the dates you'd like to participate in for this WS2024-25:

        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.