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

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