Industry Publishes Key Proposals For Development Of Companion Diagnostic Guidance

Companion diagnostics are being regulated Europe-wide for the first time under the IVD Regulation which fully applies on 26 May 2022. Industry is calling for details and guidance on how this will work.

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A joint pre-submission advice and consultation procedure for EU manufacturers of companion diagnostics is needed as a growing matter of urgency, given that these products will be regulated Europe-wide for the first time under the forthcoming IVD Regulation.

Appropriate guidance on this should be developed as soon as possible by the European Medicines Agency (EMA), together with notified bodies, the European Commission and its Medical Device Co-ordination Group...

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