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:

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/ Cluster centre for 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.

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 (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

24.05. (online) Exam 1 at 9:00 am

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 2 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)

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)

Pricing Information for Professionals:

  • 8 teaching units per single seminar topic: 400,00 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:

  • 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 Law (MPR)“ course and the examination are free of charge for students enrolled at the FAU in the degree Medical Engineering (Master und Bachelor??
  • 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

Cooperation partners: