#In-Vitro Diagnostics #Norway #Oslo #DNV #EU IVDR

DNV's Role in Advancing Diagnostic Technology

OSLO, Norway, April 7, 2026 – DNV, a prominent notified body for the European Union in-vitro diagnostic regulation (IVDR) and medical device regulation (MDR), has been chosen by a leading US diagnostics manufacturer to certify their patient-centered diagnostic devices under the IVDR framework. This significant appointment marks a pivotal moment for the manufacturer, as it ramps up their efforts to ensure compliance with European standards and to maintain vital access to the European market.

The scope of the certification involves several product families of Class D in-vitro diagnostics, categorized as the highest risk under the IVDR. These products include tests that detect life-threatening diseases with high transmission rates, thus necessitating stringent regulatory oversight prior to their entry into the European market.

With ongoing changes in regulations, manufacturers must adapt existing products to comply with the IVDR, making it increasingly important to secure the capacity of notified bodies for continuing access to European markets. The IVDR, which replaced the previous directive (IVDD) in 2017, significantly tightens the regulatory requirements in Europe, enhancing the demands for clinical evidence and increasing the involvement of notified bodies in the process.

Appointed as a notified body in May 2025, DNV brings decades of expertise in medical device certification, assisting manufacturers globally to navigate complex regulatory landscapes and secure access to international markets. The partnership between DNV and the manufacturer is not new; they have worked together in the past, certifying multiple products through various regulatory frameworks, including the Medical Device Single Audit Program (MDSAP).

DNV’s certification activities concerning the IVDR will leverage its advanced digital certification platform. This innovative technology allows manufacturers to securely upload and manage technical and performance documentation. Furthermore, the platform fosters efficient collaboration throughout the review process, enhancing workflow and transparency.

A representative from the manufacturer stated, "Having collaborated extensively with DNV on other certification systems, we trust their expertise and cooperative approach. DNV's flexible project management and their willingness to customize certification timelines made them an obvious choice for our IVDR certification. Their post-certification support also ensures a smooth transition to the new regulation."

Cecilie Gudesen Torp, VP and Managing Director of Medical Technologies at DNV, expressed pride in assisting this manufacturer in achieving IVDR certification and maintaining market access. She emphasized, "Our goal is to make the certification process as efficient and transparent as possible, combining collaborative project management with digital tools that streamline document management and communication."

In summary, DNV’s commitment to facilitating a seamless certification process heralds a new chapter for manufacturers in the diagnostics sector, ensuring that essential healthcare technologies can continue to reach markets where they are critically needed. Certified technology enables access to necessary diagnostics for patients worldwide.