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Medical Device Regulations (MGST-B-5-R-MP-ILV)
Department
- Bachelor's program Medical, Health and Sports Engineering
Course unit code
- MGST-B-5-R-MP-ILV
Level of course unit
- Bachelor
Year of study
- Fall 2024
Semester when the course unit is delivered
- 5
Number of ECTS credits allocated
- 3.0
Name of lecturer(s)
- Rubisoier Daniel, BSc MSc
Learning outcomes of the course unit
- The students
- learn basic knowledge about dealing with legal and normative requirements.
- learn basic knowledge about parts of (EU-Medical Device Regulation) legislation.
- learn differences to important other legal areas (especially the USA).
Recommended optional program components
- keine
Recommended or required reading
- - Verordnung (EU) 2017/745 des Europäischen Parlaments und des Rates vom 5. April 2017 über Medizinprodukte, zur Ände-rung der Richtlinie 2001/83/EG, der Verordnung (EG) Nr. 178/2002 und der Verordnung (EG) Nr. 1223/2009 und zur Auf-hebung der Richtlinien 90/385/EWG und 93/42/EWG des Rates
- FDA Regulatory Affairs: Third Edition, David Mantus, Douglas J. Pisano, 2014Medical Device Regulation
https://eur-lex.europa.eu/legal-content/DE/TXT/?uri=CELEX%3A32017R0745
European Commission
https://health.ec.europa.eu/medical-devices-sector/overview_en
Guidance - MDCG endorsed documents and other guidance
https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_de
Harmonised Standards
Medical devices (europa.eu)
Planned learning activities and teaching methods
- In der Lehrveranstaltung werden verschiedenste Lehr- und Lernformen (Vortrag, Einzel- und Gruppenarbeit, Diskussion, etc.) auf interaktive Art und Weise verknüpft.
Assessment methods and criteria
- Homework 1 (10%) + Homework 2 (10%) + Exam (80%) (Multiple Choice Test))
Language of instruction
- English
Work placement(s)
- keine