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  • 1.  CE-IVD for CDx in Europe?

    This message was posted by a user wishing to remain anonymous
    Posted 25-Jun-2019 09:42
    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!



  • 2.  RE: CE-IVD for CDx in Europe?

    Posted 26-Jun-2019 06:20
    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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  • 3.  RE: CE-IVD for CDx in Europe?

    Posted 26-Jun-2019 07:22
    "Unless an exemption applies, all IVDs being placed on the market or put into service in the EU are required to be CE marked. This includes devices used in clinical trials of medicines to stratify patients for inclusion/exclusion in the trial or stratified to a cohort within a trial." See: https://www.gov.uk/guidance/notify-mhra-about-a-clinical-investigation-for-a-medical-device#in-vitro-diagnostic-medical-devices-ivds

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    Michael Wienholt
    Owner & Principal Consultant
    Raleigh NC
    United States
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