Usability for Near Patient Testing Test Kit

Hi Covers,

I'm applying for IVDR certification for our Class C NPT test kit and preparing technical documentation.
Having trouble with the usability engineering and not sure about if we need to actually have a usability plan and report as part of the TD.
I searched the word "usability" in EU 2017/746 and it only appears twice.
I'm actually very unfamiliar with ISO 62366-1 and ISO TR 62366-2. I think I will just prepare a survey and have the health professionals complete it during the clinical performance study at near-patient sites and consider the usability in the risk managerment documentations.

Does anyone have similar experience and Could anyone advise me on this?

If this is a new product, I think you would need to follow IEC 62366-1, which would require use spec, use error ID with risk analysis, UI spec, and summative evaluation. If it is a legacy product, you may be able to leverage Annex C (UOUP) for the curtailed route.

Thank you sir. It has not been IVDD-CE marked so I believe it is a new product. Will read 62366-2 for guidance.