DNV Expands Certification for EU In Vitro Diagnostic Devices
DNV, a leading assurance and risk management provider, has been recognized by the European Commission as a notified body under the EU's In Vitro Diagnostic Regulation (IVDR). This designation enhances certification capacity for in vitro diagnostic devices, aiding manufacturers in accessing the EU market with a fully digital, transparent process.
- Country:
- Norway
The European Commission has designated DNV as a notified body for the certification of devices under the EU's In Vitro Diagnostic Regulation (IVDR). This recognition increases the capacity for certifying in vitro diagnostic devices, which include critical health tests such as HIV screening and COVID-19 testing.
DNV's new designation facilitates entry to the EU market by offering device manufacturers a streamlined, fully digital certification process. This approach enables faster certification and provides transparent tracking of compliance status, crucial for devices that determine personal and public health safety.
With a primary focus on risk management, DNV's involvement as a top five notified body underscores their commitment to delivering efficient and reliable certification processes. Manufacturers of IVD devices stand to benefit from DNV's global team's expertise, as devices will need IVDR compliance certification by 2025 to 2027, depending on their classification.
(With inputs from agencies.)
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