Summative Usability test

#1
Hello everyone,
First of all, thanks for all the help and replies.

I found a couple of threads that have a similar topic but don't answer my question:
Is there anything to consider from a regulatory and legal point of view if I want to carry out a summative usability evaluation according to IEC 62366 (within the EU) with 5 - 10 healthcare professionals (no patients included! and corresponding labeling like RUO). Do you might know guideline documents e.g. from MDCG?
In my opinion I don't need an ethical approval for this, am I right?
It's about a web-application (SaMD/ MDSW).
A risk analysis according to ISO 14971 is carried out beforehand.

Thank you!
 
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#2
Your assumption is correct. Since you are evaluating a SaMD (there are likely no notable risks which require human subjects protection) an ethics approval is not required. Just make sure that you thoroughly evaluate all identified critical tasks and follow-up with participants accordingly to understand the root-cause of any observed events (particulary related to critical tasks).
 
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