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ISS Named As Italy’s First Notified Body Under The EU’s IVD Regulation

 
• By Amanda Maxwell

After a hiatus of nearly a year, the EU can celebrate another designation under the IVD Regulation.

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The Istituto Superiore di Sanita, based in Rome, has become Italy’s first - and the EU’s 13th - organization to be designated as a notified body to assess products that fall under the scope of the IVD Regulation.

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The deadline for comments is 30 June 2025

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Well over 200 European standards need harmonizing under the MDR. But only around 12% have been attended to so far.

More from Geography

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• By Barnaby Pickering

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• By Elizabeth Orr

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