DNV selected to certify Class D devices for leading U.S. manufacturer under EU IVDR
Norway, March 31 -- DNV supports the manufacturer's transition to new regulation with its digital certification platform and transparent, predictable project managementDNV has been selected by a leading U.S. diagnostics manufacturer to certify near-patient diagnostic devices under the IVDR.The engagement covers several families of Class D diagnostic devices, the highest-risk category under the IVDR. These include tests used to detect life-threatening diseases with a high risk of propagation requiring the most stringent regulatory oversight before entering the European market.As manufacturers transition legacy devices to the IVDR, securing notified body capacity has become a critical step in maintaining access to the European market.The IVDR...
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