European Commission Recognizes DNV as a Notified Body for IVDR

DNV has been recognized by the European Commission as a notified body for certifying devices under the European Union’s In Vitro Diagnostic Regulation (IVDR). The designation increases capacity for certifying in-vitro diagnostic devices and providing EU market access. 

DNV offers device manufacturers a fully digital process for faster, more transparent device certification.

In-vitro diagnostics (IVDs) are tests used to determine a patient’s health status. They range from pregnancy and cholesterol tests through to HIV screening, COVID-19 assays, 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 new IVD device safety and efficacy. A certificate of compliance with the IVDR will be required for most IVD device to be sold in the EU, and devices are classified according to their risk to public and personal health. Class D devices, with the highest risk, now require IVDR certification whereas Class C and Class B will require IVDR certification from May 2026 and May 2027, respectively.

DNV’s designation as an IVDR notified body brings greater certification capacity, helping more device manufacturers access the EU market. To further streamline access to market, DNV has a fully digital certification process. Manufacturers can 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 of Medical Services, Supply Chain & Product Assurance at DNV. “Being in the top five 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 reliability to reduce risks and help manufacturers get to market faster.”

Download the IVDR compliance guide here.

DNV is an independent assurance and risk management provider operating in more than 100 countries. Through assessment and digital assurance solutions, DNV helps companies build trust and transparency around products, assets, supply chains and ecosystems. Whether certifying products, verifying claims or optimizing and decarbonizing supply chains, DNV helps companies manage risks and realize their long-term strategic goals, improving ESG performance and generating lasting, sustainable results. 

Combining sustainability, supply chain and digital expertise, DNV works to create new assurance models enabling interaction and transaction transparency across value chains. Drawing on its wide technical and industry expertise, DNV works with companies worldwide to bridge trust gaps among consumers, producers and suppliers. Driven by its purpose, to safeguard life, property, and the environment, DNV helps tackle the challenges and global transformations facing its customers and the world today and is a trusted voice for many of the world’s most successful and forward-thinking companies.