Medical Device Regulation

We are happy to announce that the Medical Device regulation seminar will commence again in the Summer semester 2025.

The registration for Summer 2025 will open on February, 25.

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 the increasingly complex subject matter of Medical Device Regulation is indispensable for any successful and competitive market entry.

The Profile Center Medical Engineering (FAU MT) 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 industry.

Please note that the seminar “Medical Device Regulation” is taught only in English.

Contact: faumt-mdr@fau.de

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

The certificate course consists of 10 individual seminar topics. In order to complete the full course successfully, it is required to

participate in all 10 seminar topics within two years
cover all topics in the end-of-semester exams successfully
reach a minimum attendance of 60% per seminar topic

The attendance of individual seminar topics is also possible without taking the exam. However, please note that you will not receive a certificate for individual sessions, you will receive a confirmation of participation instead. If you wish to receive the official course certificate, you must complete the full course.

The seminar topics are composed of professional lectures and practical parts such as group work.

Please note that filling out a registration form does not mean you’re enrolled in the course! Due to high demand and limited spots in the course, we unfortunately cannot consider every registration. We admit students on a first come, first serve basis. If you’re considered for participation in the course, you will receive an admission e-mail and will have to confirm your participation by the deadline in the e-mail to keep your spot. The rest of the registrations will be placed on a waitlist and empty seats will be filled if no confirmation of the selected students occurs. Please refer to the registration conditions in the registration form for further information regarding cancellations.

The course consists of 10 topics in total. Two topics – “Introduction to the Medical Device Regulation” and “Risk Management” – are offered in both winter and summer semesters. The remaining 8 topics are split into winter and summer topics:

In the summer semesters, we offer:

Introduction to the Medical Device Regulation
Risk Management
Clinical Evaluation
Software for Medical Devices
Medical Devices in the Field
Quality Management

In the winter semesters, we offer:

Introduction to the Medical Device Regulation
Risk Management
3D-Printing in Medical Engineering & Artificial Intelligence
Other Countries, Other Customs
Usability Engineering
Systematic MDR-Compliant Medical Product Development

The topics “Introduction to the Medical Device Regulation” and “Risk Management” only have to be attended and passed once.

Ideally, all 10 topics are attended within two semesters (1 winter semester, 1 summer semester), covering 6 topics in the first and 4 topics in the second semester. It is advised to attend the Introduction session and Risk Management in your first semester of the certificate course if possible.

Each seminar has 8 teaching units (8 x 45 minutes)

The first seminar “Introduction to the Medical Device Regulation” is always an in-person event, the rest of the seminar topics are held online. Please refer to the timetable for further information regarding the course schedule and the in-person session.

date tba – Introduction to the Medical Device Regulation (in-person)
date tba – 8:30 – 12:30 Risk management I (online)
date tba – 8:30 – 12:30 Risk management II (online)
date tba – 8:30 – 12:30 Clinical Evaluation I (online)
date tba – 8:30 – 12:30 Clinical Evaluation II (online)
date tba – 8:30 – 12:30 Software for Medical Devices I (online)
date tba – 8:30 – 12:30 Software for Medical Devices II (online)
date tba – 8:30 – 12:30 Medical Devices in the Field I (online)
date tba – 8:30 – 12:30 Medical Devices in the Field II (online)
date tba – 8:30 – 12:30 Quality Management I (online)
date tba – 8:30 – 12:30 Quality Management II (online)

Pricing Information for Professionals:

Fee per single seminar topic: 400 euros*
Examination fee per topic: 50 euros*
10 seminar topics (complete course, including examination fee): 3,500 euros*
Members of FAU MT or Medical Valley EMN e.V.: 25% Discount** for professionals only
Members of Forum MedTech Pharma e.V.: 10% Discount** for professionals only

* Tax-free according to German law §4 Nr. 22a UStG.
** Only one discount applies.

Pricing Information for Doctoral Candidates:

External doctoral candidates: 80 euros* per seminar topic
FAU’s doctoral candidates: 40 euros* per seminar topic

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

Pricing Information for Students:

Medical Engineering Students at FAU

Medical Engineering students enrolled at FAU can complete one semester with an online exam covering 6 topics and receive 2.5 ECTS. The remaining 4 topics in subsequent semesters will not be rewarded with any ECTS towards your degree; the completion of the full course by attending the remaining topics is solely to receive the course certificate.

The first semester of the certificate course (6 topics) is free of charge for Medical Engineering students at FAU.