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

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  Post Number #1  
Old 11th July 2018, 09:40 AM

Total Posts: 3
Question IVDD - IFU related requirements - Type of information/statement expected

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!

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  Post Number #2  
Old 15th July 2018, 03:15 AM
Marc's Avatar

Total Posts: 26,672
Re: IVDD - IFU related requirements - Type of information/statement expected

My Thanks in advance to anyone who can help with this one. "Bump"

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