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
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
