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 winter semester 2021/2022, it’s taking place via zoom.

Further Information about the Seminar „Medical Device Regulation MDR“ (Flyer, 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.

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 October 2021, 8:30 a.m. to 12:30 p.m.
    Dr. Maria Henke & Christian Sauter
  • „Introduction to the medical device law – Part 2“, Wednesday 03 November 2021, 8:30 a.m. to 12:30 p.m.
    Dr. Maria Henke & Christian Sauter
  • „Risk management – Part 1“, Wednesday 17 November 2021, 8:30 a.m. to 12:30 p.m.
    Christian Sauter
  • „Risk management – Part 2“, Wednesday 24 November 2021, 8:30 a.m. to 12:30 p.m.
    Christian Sauter
  • „Software for Medical Devices – Part 1“, Wednesday 15 December 2021, 8:30 a.m. to 12:30 p.m.
    Dr. Matthias Hölzer-Klüpfel
  • „Software for Medical Devices – Part 2“, Wednesday 22 December 2021, 8:30 a.m. to 12:30 p.m.
    Dr. Matthias Hölzer-Klüpfel
  • „Clinical Evaluation – Part 1“, Wednesday 12 January 2022, 8:30 a.m. to 12:30 p.m.
    Cesare Magri & Christiane Reinwald
  • „Clinical Evaluation – Part 2“, Wednesday 19 January 2022, 8:30 a.m. to 12:30 p.m.
    Cesare Magri & Christiane Reinwald
  • „Medical Devices in the field – Part 1“, Wednesday 26 January 2022, 8:30 a.m. to 12:30 p.m.
    Dr. Stefanie Spallek & Johannes Spallek
  • „Medical Devices in the field – Part 2“, Wednesday 02 February 2022, 8:30 a.m. to 12:30 p.m.
    Dr. Stefanie Spallek & Johannes Spallek
  • „Quality Management – Part 1“, Wednesday 16 February 2022, 8:30 a.m. to 12:30 p.m.
    Stefan Bolleiniger
  • „Quality Management – Part 1“, Wednesday 23 February 2022, 8:30 a.m. to 12:30 p.m.
    Stefan Bolleiniger

Seminar topics for summer semester:

  • Introduction to the Medical Device Law
  • Risk Management in Medical Engineering
  • Medical Device Regulation
  • Quality Management
  • Medical Devices in the Field
  • Other Countries, other Customs: USA, China, Brasil, Japan, Canada, Australia

Pricing Information for Professionals:

  • 8 teaching units per single seminar topic: 346,00 Euro (incl. VAT)
  • 80 seminar topics (complete course, including examination fee): 3.300,00 Euro (incl. VAT)
  • 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*

* 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

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 the field of Medical Engineering.
  • For Medical Engineering students (FAU): more than 6 seminar topics: 35 Euro per seminar topic.
  • Other students of the Master‘s program in medical engineering are allowed to participate in 6 seminar topics free of charge. For each additional course, a fee of 35 Euros is required.

Examination

  • For the university certificate, all 10 seminar topics must be attended within 2 years, the exams are taken separately.

Registration form for Professionals and Doctoral Candidates
Please follow this link to register (Registration Form only in English)

Registration form for Students
For students, the registration is ALREADY CLOSED.

Registration period WS21/22:
15th September 2021 – 04th October 2021

Participants‘ Confirmation (via mail):
11th October 2021


Partners: