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Introduction to Instructions for Use, including the EIFU of Medical Devices Regulation (EU) 2021/2226

This course covers an introduction to Instructions for Use (IFU), including Electronic Instructions for Use (EIFU), giving participants a strong foundational knowledge in meeting the requirements of the law.

Course Details

The aims and learning outcomes of this course are:

  • To understand the requirements of GSPR 23.
  • To understand the requirements of EU 2021/2226.
  • To understand the ties between risk, the IFU, and labelling.

Following completion of this course, participants should:

  • Possess the required knowledge to implement the IFU.
  • Be able to construct a label which complies with the Regulations.
  • Understand where EIFUs are appropriate, and how to implement them. 

This is a one-day course in which participants will fully engage with the lecturer through group and individual exercises.  There are plenty of opportunities to ask questions, and the course can be fully tailored to the company’s products and internal structure. 

This course explores the Medical Devices Regulation (EU) 2021/2226 in three modules.

  1. Introduction.
  2. Instructions for Use (IFU).
  3. EIFU.