The current regulation for Europe is the In Vitro Diagnostic Medical Device Regulation - IVDD - 98/79/EC applicable for IVDs to identify patients likely to respond to particular treatment. However what you will find is there is nothing in there about regulating a CDx IVD product. Well not exactly a valid statement ... yes you can find how the device would be regulated which would most likely fall under General IVD - therefore the reason the entire classification structure changed to what it is under the IVDR (EU) 2017/746.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 25-Jun-2019 09:28
From: Anonymous Member
Subject: CE-IVD for CDx in Europe?
This message was posted by a user wishing to remain anonymous
Could someone please point me to the current regulation (not IVD-R) that mandates CE-IVD for an IVD to identify patients most likely to respond to particular treatment (would be a CDx in US) running out of a central lab in Europe (e.g. no kit or reagents being commercialized or distributed)?
Thank you!