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 winter semester 2021/2022, it’s taking place on-site, in Erlangen. Exact room: tbd.

Further information about Medical Devices Law (Flyer, only in German)

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.

This winter semester 2021/22, the Seminar “Medical Device Law” (MPR) is going to be on-site.
Venue: Medical Valley Center, Henkestraße 91, 91052 Erlangen (Konf. Raum2)

  • “Einführung in das Medizinprodukterecht”, Wednesday 20 October 2021 (9 a.m. – 5 p.m.)
    Dr. Maria Henke & Christian Sauter
  • “Risikomanagement in der MT”, Wednesday 10.11.2021 (9 a.m. – 5 p.m.)
    Christian Sauter
  • “Digital Health”, Tuesday 16 November 2021 (9 a.m. – 5 p.m.)
    Tobias Schreiegg
  • “Software für Medizinprodukte”, Wednesday 08 December 2021 (9 a.m. – 5 p.m.)
    Dr. Matthias Hölzer-Klüpfel
  • “Klinische Bewertung”, Wednesday 12 January 2022 (9 a.m. – 5 p.m.)
    Raymond Glocker: To be confirmed!
  • “Usability Engineering”, Thursday 20 January 2022 (9 a.m. – 5 p.m.)
    Michael Engler

Seminar topics for summer semester:

  • Einführung in das Medizinprodukterecht
  • Risikomanagement in der MT
  • Medical Device Regulation
  • Qualitätsmanagementsysteme in der MT
  • Medizinprodukte im Feld
  • Andere Länder, andere Sitten: USA, China, Brasilien, Japan, Kanada, Australien

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: 50% Discount
  • 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.
  • 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.

Professionals and Doctoral candidates:
Please follow this link to register (MPR Registration form only in German)
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.

Students:
Please follow this link to register (MPR Registration form only in German)
For students, the registration is open until 04 October 2021

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

Participants’ Confirmation (by e-mail):
11th October 2021


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