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Will MDR Delays Create Roadblocks For Companion Diagnostics Regulation?

 
• By Amanda Maxwell

Companion diagnostics are needed increasingly by pharma companies to justify the safety and effectiveness of their products. With specific first-time EU regulation of these products within sight – and urgently needed – is there a risk of delays to these products being able to demonstrate compliance?

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• Source: Shutterstock

The EU IVD Regulation (IVDR), which will fully apply on 26 May 2022, defines exactly what companion diagnostics (CDx) are, and specifically regulates these products for the first time in the EU. But what is the likelihood of CDx manufacturers being unable to comply with the IVDR by the 2022 deadline?

There are concerns about the IVD regulatory structure not being sufficiently ready by the date of application. While much of...

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