How do you validate and test your medical device IFU (Instructions For Use)?

Question

Our team has previously added one or two tests about the IFU to our usability tests, but this approach felt awkward for testers and did not cover the entire IFU. We are seeking practical methods to validate the IFU in a meaningful way that satisfies notified body expectations. 
How do others approach IFU validation? Are there specific processes, questionnaires, or methods you have found effective for ensuring users understand the IFU and that it covers all regulatory requirements?

Dr. Oliver Eidel · Accepted Answer

We've written a questionnaire with about 5-6 questions for users to answer after reviewing the IFU. The main focus is whether the instructions are clear, if the user can perform all steps, and if they understand the warnings after reading the IFU.
It's pretty flexible—you can choose what to test for, but a risk-based approach works well. If there are critical points in your IFU, design your testing to make sure users notice and understand them. This way, you can show the notified body that the IFU is effective and covers all necessary points.

Answer

We have a set of validation test cases that refer to the IFU to verify that all required information is present. Additionally, we run a general test where testers read specific sections to confirm legibility and clarity. We haven't required everyone to read the full IFU—just the parts relevant to their role and the most critical sections.

Answer

A notified body will expect proof that the IFU content is understood by users and that all General Safety and Performance Requirements (GSPRs) are fulfilled. For the GSPRs, you can simply check off a checklist.
During usability testing, the IFU is central for instructing users. You can observe tasks performed according to the IFU and/or have users fill in a questionnaire about the IFU, focusing on the highest risks. The final report can then serve as evidence in your risk management.
How many people you involve depends on your general approach to usability testing. If reading the full IFU is necessary for safe use, include that as part of the test; otherwise, focus on the critical sections.

Answer

From what I've seen, reading the IFU should sufficiently inform the user to use the product. It doesn't matter if you validate it during usability testing or separately. Especially with software as a medical device, you need to consider how users perceive and understand the instructions, and check if they can perform the tasks. Even though most users don't read IFUs, the notified body still needs to see that you've checked the document's clarity and usefulness.

How do you validate and test your medical device IFU (Instructions For Use)?

4 Answers

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