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IVD Reagent Techncial File Review Requirements (IVDD Annex III)

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  Post Number #1  
Old 17th October 2014, 02:43 PM

Total Posts: 5
Please Help! IVD Reagent Techncial File Review Requirements (IVDD Annex III)


I work for an IVD reagent company, who manufactures hundreds of clinical chemistry reagents. All of our reagents are self certified and conform to IVDD Annex III. Currently, each reagent has its own technical file, and it takes many months to review and update these files every two years.

My question is: can we group the reagents into a few types? Based on diagnostic panels, analyts structures, claims, levels of risks, manufacturing processes, etc. we will have a lot less files to update.

Thank you for your help.

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  Post Number #2  
Old 21st October 2014, 10:14 PM
Stijloor's Avatar

Total Posts: 15,334
Re: IVD Reagent Techncial File Review Requirements (IVDD Annex III)

A Quick Bump!

Can someone help?

Thank you very much!!
  Post Number #3  
Old 22nd October 2014, 08:34 PM
GStough's Avatar

Total Posts: 1,213
Re: IVD Reagent Techncial File Review Requirements (IVDD Annex III)

I can't help, but would definitely be interested in seeing others' responses.
  Post Number #4  
Old 29th October 2014, 07:02 AM

Total Posts: 824
Re: IVD Reagent Techncial File Review Requirements (IVDD Annex III)

I am not an IVD expert but nobody else appears to have answered.

It is certainly possible within the MDD to use a single file to cover a number of different devices. Technical files can be structured how you like as long as the required information exists
  Post Number #5  
Old 2nd November 2014, 10:08 PM

Total Posts: 541
Re: IVD Reagent Techncial File Review Requirements (IVDD Annex III)

If the intended use statement is "same" and if falls under the same "GIVD/EDMA" code, then "yes", you can have all of them in a single EC Declaration of Conformity under one Technical file.


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