EU Needs Feedback On Draft Requirements For Seven High-Risk IVD Test Categories

Two years after the EU adopted the original common specifications for certain products under the IVD Regulation, the commission has added new products and updated its requirements.

Zika Mosquito — Tests For Zika Virus Are Among Those Listed For Tighter Requirements

September 16 is the deadline for feedback on the European Commission’s text amending the 2022 implementing regulation that lays down common specifications (CS) for certain class D IVDs (the highest risk products) in the context of the IVD Regulation.

The updated proposed text outlines new detailed CS for detection of:

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