The EU has published a total of 61 pages of technical specifications for the higher risk, Class D products under the new IVD Regulation.
After a long wait, the European EU Commission has finally adopted an Implementing Regulation laying down the Common Specifications (CS) for certain Class D IVDs in the context of the IVD Regulation. The IVDR took effect some six weeks ago and the new requirements have still to be published in the Official Journal of the EU.
Class D is the highest risk category under the new IVDR, and legacy IVD Class D must be in full compliance with the new rules by 26 May 2025. New...
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The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.
