Medical Devices Law (MPR)

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 German market (in German).

The certificate course “Medical Devices Law” 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.

Please notice that the seminar “Medical Device Law” is taught only in German and that during the upcoming summer semester 2022, it’s taking place on-site, in Erlangen.
Venue: Central Institute of Medical Engineering, Henkestraße 127, 91052 Erlangen (Ground floor)

Course objectives

  • 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.

Seminar topics and dates for Summer Semester 2022

This summer semester 2022, the Seminar “Medical Device Law” (MPR) is going to be on-site.
Venue:
Seminarraum ZMPT – 00.020
Henkestraße 91, 91052 Erlangen

  • “Einführung in das Medizinprodukterecht”, Wednesday 04.05.2022 from 9am-17pm
    Dr. Maria Henke & Christian Sauter
  • “Risikomanagement in der Medizintechnik”, Wednesday 25.05.2022 from 9am-17pm 
    Christian Sauter
  •  “Medical Device Regulation”, Wednesday 08.06.2022 from 9am-17pm 
    Stefan Bolleininger
  • “Medizinprodukte im Feld”, Wednesday 29.06.2022 von 9-17 Uhr
    Dr. Stefanie & Johannes Spallek
  • ONLINE > “Other countries, other customs Part 1”, Wednesday, 06.07.2022 from 8:30am – 12:30pm
    Volker Glahn
  • ONLINE > “Other countries, other customs Part 2”, Wednesday, 13.07.2022 from 8:30am – 12:30pm
    Volker Glahn
  • New date > “Qualitätsmanagement in der Medizintechnik”, Wednesday 20.07.2022 from 9am-17pm 
    Dr. Holger Brünner

Seminar topics for Winter semester:

  • Medizinprodukterecht
  • Risikomanagement in der MT
  • Klinische Bewertung
  • Usability Engineering für Medizinprodukte
  • Software für Medizinprodukte
  • Digital Health

Pricing Information

Pricing Information for Professionals:

  • 8 teaching units per single seminar topic: 346,00 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:

  • Doctoral candidates: 70,00 Euro* pro seminar topic.
  • FAU’s Doctoral candidates: 35,00 Euro* pro seminar topic.
  • One time examination: 186,00 Euro*

* 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 FAU in Medical Engineering.
  • For Medical Engineering students (FAU): more than 6 seminar topics: 35 Euro* per seminar topic.
  • Students of other subject-related courses enrolled at FAU: 35 euros* per seminar topic.

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

Examination

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

Registration form for Professionals

Registration form for professionals, under this link

Please register at least one week before the seminar day you’d like to participate.
We’ll confirm your participation by e-mail.
Please notice that the number of participants is limited.

Registration form for Doctoral Candidates

Registration form for Doctoral Candidates, under this link

Please register at least one week before the seminar day you’d like to participate.
We’ll confirm your participation by e-mail.
Please notice that the number of participants is limited.

Registration form for Students

  • Registration period SS22:
    04th April – 17th April 2022 (via registration form)
  • Participants’ Confirmation (by e-mail):
    20th – 22nd April 2022


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