How To Comply With New Requirements For Companion Diagnostics Under IVDR

The regulation of companion diagnostics will be far stricter under the IVDR than the current IVD Regulation. EU life sciences regulatory lawyer Elisabethann Wright provides an overview and explains how companies should prepare for compliance.  

Hurdles
Regulatory hurdles ahead for companion diagnostics

Elisabethann Wright 

Manufacturers who currently supply CE-marked IVDs in the EU will face challenging hurdles in the short term as they seek...

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