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
Einführung in das Medizinprodukterecht on YouTube
- YouTube Playlist: “Einführung in das Medizinprodukterecht” (only in German)
- Zusammenfassung Beziehungen der Akteure (only in German)
- Zusammenfassung Gesetze und Normen (only in German)
- Überblick von der Idee zum Markt (only in German)
- YouTube Playlist “Introduction to Medical Device Regulation”
- Risk Management in the medical device industry in the EU
- Quality Management Systems in the medical device industry in the EU
- Usability Engineering in the medical device industry in the EU
- Post-Market Surveillance in the medical device industry in the EU
Cooperation partners: