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How Should We Classify Our IVD Device under the IVDR?

How Should We Classify Our IVD Device under the IVDR?

As the manufacturer of legacy IVD devices, you face the challenge of reclassifying your product portfolio using the new risk-based classification rules, outlined in Annex VIII of the IVDR 2017/746.  There are still some grey areas, which I shall clarify during this...