Medical Device Regulation

We are happy to announce that the Medical Device regulation seminar will commence again in the summer semester 2024. We will be opening the registrations on: 

15 March 2024 

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.


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.

MDR Seminar topics

  • 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)


26 April 2024 (kick-off in person) 8:30 – 18:00 Introduction to Medical Device Regulation 1&2

29 April 2024 (online) 8:30 – 13:00 Risk Management 1

06 May 2024 (online) 8:30 – 13:00 Risk Management 2

27 May 2024 (online) 8:30 – 13:00 Software for Medical Devices 1

29 May 2024 (online) 8:30 – 13:00 Software for Medical Devices 2

05 June 2024 (online) 13:30 – 18:00 Clinical Evaluation 1

06 June 2024 (online) 13:30 – 18:00 Clinical Evaluation 2

18 June 2024 (online) 8:30 – 13:00 Medical Devices in the Field 1

19 June 2024 (online) 8:30 – 13:00 Medical Devices in the Field 2

03 July 2024 (in person) 8:30 – 17:30 Quality Management 1&2

Pricing Information

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*

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

Registration Professionals

Registration is closed.

Registration Doctoral Candidates

Registration is closed.

Registration Students

Registration is closed.