Medical Device Regulation and the design of Medical Devices

Introduction

As of May 2021 the new Medical Devices Regulation (EU) 2017/745 became applicable. In this course, you will learn on how the European Medical Devices Regulation (MDR) puts strict demands on the (design of) medical devices that should be met before it can be used in a hospital. The contents of this course touch upon several aspects in the process of obtaining a CE-mark: risk management, design and manufacturing, clinical evaluation, and compiling the required documents. PhDs will present and discuss their work every week in live sessions.

Learning objectives

After completion of the course, PhD candidates should be able to:

  • Explain what the Medical Device Regulation, norms, and standards are;
  • Explain the steps required for obtaining a CE mark, and the rules concerning clinical research with a medical devices;
  • Motivate why a device should (not) be considered as a medical device based on the Medical Device Regulation (MDR 2017/745);
  • Classify medical devices based on their intended purpose according to the Medical Device Regulation;
  • Formulate and structure the intended uses and foreseeable misuses of a medical device using a process tree;
  • Analyse hazards, harms and risks associated with the use and misuse of a medical device according to ISO 14971:2019, and perform a risk-benefit analysis;
  • Evaluate a medical device against its requirements, including the safety, cleanability, and manufacturability, and the suitability of a medical device for implementation in practice;
  • Improve the design of a medical device and its materials to improve its safety .
  • Propose plans for functional and clinical assessment of a medical device according to the guidelines (MDR and ISO 14155:2020);
  • Present your results, facts and opinions efficiently, professionally and effectively.

Required background

Affinity with the development of medical devices, and preferably having a(n) (early) medical device prototype available (along with design drawings, CAD files, etc.).

Course material

  • Medical Devices Regulation (EU) 2017/745
  • ISO 14971:2019 / ISO TR 24971:2020: Medical devices — Application of risk management to medical devices
  • ISO 13485:2016: Quality management systems
  • ISO 10993:2018: Biological evaluation of medical devices

Course documents will be provided.

ECTS credits:
2.0 Ects (=5GSC)

Lecturer(s):
Prof.dr. J. Dankelman, Dr.ir. A. Loeve, R. Straathof MSc.

Course dates:
2023 (specific dates will be announced)

Schedule:

  • Week 1: General background on MDR and CE marking 
  • Week 2: Risk analysis
  • Week 3: Redesign  
  • Week 4: Technical documentation and CE marking
  • Week 5: Clinical evaluation of your medical device in the hospital

Group sizes:
The course will be offered for a minimum of 4 and a maximum of 8 participants per session.

Assessment:
Participation in discussion sessions and final document.

Contact:
PhD candidates wishing to participate should contact Prof.dr. J. Dankelman and R. Straathof MSc. by email along with preferred dates.

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