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.

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

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