University of Galway

Course Module Information

Course Modules

Semester 1 and Semester 2 | Credits: 5

This module integrates the principles behind medical device design and subsequent EU regulation towards gaining a fundamental understanding of contemporary medical challenges, medical device design, the medical device regulatory process and clinical translation. The module gives an introduction to how devices are designed. Concepts of design of biomaterials systems for the intended applications with the evolving paradigm of biocompatibility will be elucidated. Guiding biomechanical principles required for these designs will also be covered. Students will also be exposed to future strategies involving nanotechnology and regenerative medicine concepts. The translation process of how devices are tested and transformed into market will be discussed. Students will learn the process of assessment of clinical need/market, select the optimal treatment strategy and decide on the particular design factors of a medical device which need to be considered for a particular application. The module introduces the student to the existing governing regulatory framework along with its associated concepts and definitions. It discusses the importance of regulation in balancing the competing requirements of early access to innovative medical device technologies and upholding the highest standards of safety and quality. The roles and responsibilities of the key stakeholders in the medical device regulatory process including Manufacturers, Competent Authorities and Notified Bodies are discussed and the essential components of the conformity assessment and CE marking process are elucidated. Accordingly, device classification, conformity assessment routes, clinical data, clinical evaluation and investigations as well as the importance of post-market surveillance and vigilance are covered in greater detail. In addition, selected case study examples are given of how the Manufacturer navigates the medical device regulatory process from the early stages of development to market.
(Language of instruction: English)

Learning Outcomes
  1. Have an understanding of the multi- and inter-disciplinary nature of the medical device field.
  2. Understand the concepts of biocompatibility.
  3. Understand the processes involved in biomaterials and biomechanics principles in designing medical devices.
  4. Be able to have an insight in the medical device industry in Ireland.
  5. Understand the legislative framework for medical device regulation in the EU.
  6. Determine if a device or product qualifies as a “medical device”, “active implantable medical device”, “in vitro diagnostic medical device” or “drug-device” combination under the definitions contained within the Directives.
  7. Describe the importance and process of medical device classification and outline the criteria used in the classification process.
  8. Explain the purpose and process of CE marking and the role of competent authorities and notified bodies in regulation of medical devices in Europe.
  9. Define and explain the importance of essential requirements, the process of conformity assessment and the use of harmonised standards.
  10. Define and explain the role of clinical data, clinical evaluation and clinical investigations. Outline post market surveillance and vigilance reporting requirements.
  11. Outline the basis for revising the EU Medical Device Regulatory Framework and explain the key changes which will be introduced.
Assessments
  • Continuous Assessment (100%)
Teachers
Reading List
  1. "Principles of Tissue Engineering," by R Lanza, R Langer and J Vacanti
    Publisher: Elsevier
  2. "Biomaterials Science (Third Edition) An Introduction to Materials in Medicine" by Buddy D. Ratner, Allan S. Hoffman, Frederick J. Schoen and Jack E. Lemons
    ISBN: 978-0-1.
    Publisher: Elsevier
The above information outlines module MD8000: "Fundamentals of Medical Device Design and Regulation" and is valid from 2018 onwards.
Note: Module offerings and details may be subject to change.