Product Approval

Department

Bachelor's program Medical, Health and Sports Engineering

Course unit code

MGST-B-5-R-PZ-ILV

Number of ECTS credits allocated

3.0

Name of lecturer(s)

Mode of delivery

face-to-face

Recommended optional program components

none

Recommended or required reading

- Regulation (EU) 2017/745 of the European Parliament and of the Council of April 5, 2017, on Medical Devices, amending Directive 2001/83/EC, Regulation (EC) No. 178/2002, and Regulation (EC) No. 1223/2009, and repealing Council Directives 90/385/EEC and 93/42/EEC
- *FDA Regulatory Affairs: Third Edition*, David Mantus, Douglas J. Pisano, 2014

Level of course unit

Bachelor

Year of study

Fall 2025

Semester when the course unit is delivered

5

Language of instruction

English

Learning outcomes of the course unit

The students:
- gain basic knowledge about handling legal and normative requirements.
- acquire basic knowledge of parts of (European) legislation.
- learn the differences to important other legal systems (especially the USA).

Course contents

- CE Marking / New Approach
- History and transition from MDD to MDR
- Scope of the MDR in relation to the product lifecycle
- Key differences to FDA requirements
- Classification of medical devices
- Manufacturer's responsibilities
- Conformity assessment procedures

Planned learning activities and teaching methods

The course comprises an interactive mix of lectures, discussions and individual and group work.

Work placement(s)

none