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)
  • Morillo Rascon Aitor, MSc, Morgan Adrianne, BA Hons, Gfoeller Elizabeth, MA
Mode of delivery
  • face-to-face
Recommended optional program components
  • none
Recommended or required reading
  • EU: key sources
    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 - https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng
    Blue Guide - https://single-market-economy.ec.europa.eu/news/blue-guide-implementation-product-rules-2022-published-2022-06-29_en

    links to key sources:
    US: https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation
    IMDRF: https://www.imdrf.org/



    Prep reading in advance for lectures:

    Lectures 1 and 2: slides will be uploaded in advance in Sakai and should be read.

    Lecture 3: reading in advance: MDR Annex VIII, MDCG 2021-24, MDCG 2019-11 & lecture 3 slides on Sakai

    Lecture 4: reading in advance: MDR Article 52, Annex IX, X, XI & lecture 4 slides on Sakai

    Lecture 5: reading in advance: MDR Annex I (3) 23 & lecture 5 slides on Sakai

    Lecture 6: reading in advance: MDR Annex I (3) 23 & lecture 6 slides on Sakai

    Lecture 7: reading in advance: MDR Annex XIV, Chp II & Article 61 & lecture 7 slides on Sakai

    Lecture 8: reading in advance: MDR Chp VII Article 83-92, Annex III & lecture 8 slides on Sakai

    Lecture 9: reading in advance: FDA Device Advice Intro & lecture 9 slides on Sakai

    Lecture 10: reading in advance: lecture 10 slides on Sakai

    Lecture 11: reading in advance: lecture 11 slides on Sakai

    Lecture 12: reading in advance: lecture 12 slides on Sakai
Additional information about examination modalities
  • Course with final examination
Level of course unit
  • Bachelor
Year of study
  • Fall 2026
Semester when the course unit is delivered
  • 5
Language of instruction
  • English
Learning outcomes of the course unit
  • The students:
    - introduction to the fundamental regulatory principles and requirements.
    - understanding the strategic importance of defining smart regulatory strategies to get to market.
    - acquire basic knowledge of key parts of (European) legislation.
    - learn the differences to important other legal systems (US, MDSAP and other key markets).
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

Back

We use cookies on our website. Some of them are essential for the operation of the site, while others help us to improve this site and the user experience (tracking cookies). You can decide for yourself whether you want to allow cookies or not. Please note that if you reject them, you may not be able to use all the functionalities of the site.

Accept Decline
Privacy Policy