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EMA to Wait for More Experience Before Issuing Guidance on Companion Diagnostics

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Known for its relatively relaxed regulations on companion diagnostics (CDx), guidance from the European Medicines Agency is not expected until there is more experience with these drug-device products, an expert says. Nevertheless, the regulation of CDx in Europe is likely to change under an upcoming revision of the European Commission’s in vitro diagnostic (IVD) directive. The revision, which will result in an EU-wide IVD regulation, would make CDx Class C devices and require notified body involvement for review of technical documentation, Bruno Flamion, former chair of the EMA’s Scientific Advice Working Party, said.
International Medical Device Regulatory Monitor