Created the rationale for why it did not needed clinical data, including the question on "direct benefit", and justified that by being in conformity with all current applicable standards, by having all possible risks analyzed and controlled, but having a very low count of adverse events, and that the benefit the device give could not be directly measured by clinical data (and there's some more justification, but for this discussion's sake, I just gave some examples), then we did conclude that it was not deemed appropriate to verify conformity with the specific ERs with clinical data, and that all of the above was enough to shoe conformity with the related requirements (again, I'm simplifying here what we did).
Also, this situation I mentioned is very, very common.