Hello Anon,
I would also say you are probably not going to find a definition of "reagent" in a regulation beyond general term used in laboratory testing. This term like others, e.g. assay, analyte, marker, are often used interchangeably, in different context, and depending on who you are speaking with, i.e. a regulator or a scientist. I would say your best location for a definition of reagent is with CLSI
https://htd.clsi.org/listterms.asp?searchd (which is also not specifically there) who are generally recognised for analytical testing standards, i.e. EP5, EP26. What I would recommend is you clearly define reagent (and any other terms) within your quality system so this is clear at least for your products.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 04-Feb-2022 02:47
From: Erik Vollebregt
Subject: IVDR - EU Definition of Reagent
I would look at the chemistry definition of reagent for this undefined concept, which is very broad. And then place this in the context of the defintion of IVD in the IVDR to confirm that the buffer fits the definition (especially the in vitro diagnostic intended purpose). There are other CE marked extraction buffer products on the market, so that's an indication.
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Erik Vollebregt
Partner
Amsterdam
Netherlands
Original Message:
Sent: 03-Feb-2022 12:13
From: Anonymous Member
Subject: IVDR - EU Definition of Reagent
This message was posted by a user wishing to remain anonymous
Hi,
Can anyone help out with a particular EN/ISO Standard that defines "Reagent". I was not able to locate a definition for "Reagent" in the IVDR.
Thanks
Note: Would like to confirm that an "extraction buffer" in a IVD test kit for the flu would be classified as a reagent.