The Impact of the IVDR on the CDx Industry: A Perspective from the Biopharma

The In Vitro Diagnostic Regulation (IVDR) is a regulation of the European Union (EU) governing the marketing and use of in vitro diagnostic medical devices (IVD). IVDR introduced an official definition of companion diagnostics (CDx) and new classifications for IVD in which CDx are classified in class C, the second highest risk level.

The regulation has been adopted in May 2017 followed by an initial 5-year transition period which ended on the 26th of May 2022. In January 2022 the European Parliament and Council approved an amendment setting new dates of application for some of the regulation’s requirements, meaning its progressive roll-out according to the class that the device is found. Under the new regulation, the assessment process for CDx requires submitting the diagnostic documents to the notified body. The notified body then assess them and conduct further consultation with the European Medicines Agency (EMA) to grant market approval.

We were keen to understand what impact the biopharma industry anticipates the IVDR to have on the processes of submission, evaluation and approval of CDx as well as on the co-development and partnership activities. We, therefore, conducted in-depth qualitative market research to uncover the concerns of biopharma companies in regards to the new regulation.

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