Module ME4520-KP04
Introduction to Medical Device Regulation (EinfMPR)
Duration
1 Semester
Turnus of offer
each winter semester
Credit points
4
Course of studies, specific fields and terms:
- Master Medical Informatics 2019, optional subject, Interdisciplinary modules
- Master Interdisciplinary Courses, optional subject, Interdisciplinary modules
Classes and lectures:
- ME4520-V: Introduction to Medical Device Regulation (lecture, 2 SWS)
- ME4520-S: Introduction to Medical Device Regulation (seminar, 1 SWS)
- ME4520-Ü: Introduction to Medical Device Regulation (exercise, 1 SWS)
Workload:
- 60 hours in-classroom work
- 60 hours work on an individual topic with written and oral presentation
Contents of teaching:
- Regulatory framework for the marketing of medical devices in the EU
- Requirements for manufacturers of medical devices
- Application of risk management to medical devices
- Application of usability to medical devices
- Quality management for medical device manufacturers
- Clinical evaluation of medical devices
- Software as a Medical Device
- Requirements for medical devices incorporating Artificial Intelligence
Qualification-goals/Competencies:
- Students describe the regulatory framework for the marketing of medical devices in the EU.
- They explain the concepts of regulatory requirements in the development, production, marketing, distribution, operation, maintenance and market surveillance of medical devices.
- They recognize and justify which requirements are relevant for a product.
- They apply norms and standards specifically to comply with requirements.
- They are proficient in risk analysis and assessment methods.
- They use elements of the usability-oriented development process.
- They assess the quality of a clinical evaluation and a software lifecycle processes.
- They compile contents of the technical documentation.
Grading through:
- portfolio exam
Responsible for this module:
Literature:
- will be announced :
Language:
- offered only in German
Notes:
Admission requirements for taking the module:- None
Admission requirements for participation in module examination(s):
- None
Module Exam(s):
ME4520-L1: Portfolio Exam Introduction to Medical Device Regulation with a total of 100 points, divided as follows:
- 70 points for active participation in the classroom sessions and group work, submission of homework assignments
- 20 points for elaboration and presentations
- 10 points for an e-test
An ungraded Category B Certificate of Achievement will be awarded.
The course is divided into three parts: The part Basic Knowledge is the basis for the course parts General Requirements and Software Requirements and must be completed by all students. Students can choose between the two other parts of the course.
The module focuses on medical device law from the perspective of manufacturers and developers of medical devices. However, the module is not only aimed at future technical developers of medical devices but all those who can contribute to the design of medical devices in interdisciplinary teams.
A maximum of 40 students can participate in one semester.
Last Updated:
02.10.2025