DNV, the independent assurance and risk management provider, has been recognised by the European Commission as a notified body for the certification of devices under the European Union’s In Vitro Diagnostic Regulation (IVDR). The designation increases capacity for certifying in vitro diagnostic devices and providing access to the EU market.
DNV offers device manufacturers a fully digital process for faster, more transparent device certification.
In vitro diagnostics (IVDs) are tests used to determine a person’s health status. They range from pregnancy and cholesterol tests through to HIV screening, COVID-19 tests and cancer marker detection. The safety and effectiveness of such devices is therefore crucial to public and personal health.
The EU introduced the IVDR in 2017, replacing its previous In Vitro Diagnostic Directive 98/79/EC (IVDD). The IVDR provides a regulatory basis for establishing the safety and effectiveness of new IVD devices. A certificate of compliance with the IVDR will be required for most IVD device to be sold in the EU. Devices are classified according to their risk to public and personal health. Class D devices, with the highest risk, will require IVDR certification from May 2025. Class C and Class B will require IVDR certification from May 2026 and May 2027 respectively.
The designation of DNV as an IVDR notified body brings greater capacity to the certification market, helping more device manufacturers access the EU market.
To further streamline access to market, DNV has a fully digital certification process. Manufacturers will be able to manage certification documents online and track compliance status in real time via a secure digital platform, for faster certification with greater transparency.
“DNV is looking forward to working with manufacturers of all classes of IVD devices to help them access the EU market,” said Cecilie Gudesen Torp, Global Director Medical Services, Supply Chain & Product Assurance at DNV. “Being in the top 5 notified bodies for medical device certification, we offer extensive expertise and technical competence. Our global team of auditors, technical assessors and clinicians are ideally positioned to deliver efficient certification with uncompromising reliability to reduce risks and help manufacturers get to market faster.”
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