IVDD - IFU related requirements - Type of information/statement expected

#1
Hi and welcome everyone first of all (been using the Cove for a while now, but this is my first post).

I'm looking for some explanation what type of information/statement is expected to show compliance with the requirements listed in the Annex I, section B, clause 8.7:
point 8.7 (j): measures to be taken in the event of changes in the analytical performance of the device

point 8.7 (k): information appropriate to users on:
— internal quality control including specific validation procedures,
— the traceability of the calibration of the device

point 8.7 (l): the reference intervals for the quantities being determined, including a description of the appropriate reference population

I know that the Directive states "where appropriate, the IFU must contain the following particulars", so it may not be always required.

Thanks for help!
Jacek
 
Elsmar Forum Sponsor
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