We’re currently planning our IEC 62366 - compliant Summative Usability Evaluation, which means that we’ll be doing usability testing with our software. We’ve got a group of test users and have prepared a protocol which lists the steps they need to perform. Now we’re wondering what the requirements for documentation of this user test are - do we need video recordings? Screen recordings? That would make things more difficult. We want to get it right the first time and minimize the risk of having to re-do user tests.
No, you don’t need video and screen recordings.
There are no hard requirements for user testing. At minimum, you need some sort of proof that you did it, which steps were performed and any usability problems you encountered (and whether you solved them). The minimum viable implementation of this would be a simple protocol per user test which includes the steps performed, whether they were performed successfully and which problems were encountered.
Video and/or screen recordings are nice to have for your internal purposes but not a must from a regulatory perspective.
Don’t forget to have a sufficiently large number of users (at least five).
Good luck! :)