DNV achieves recognition as a notified body for in vitro diagnostics certification
- DNV has been recognized as a notified body for the certification of IVD devices under the IVDR.
- The IVDR replaces the previous directive and requires compliance certification for IVDs to be marketed in the EU.
- This recognition helps streamline the certification process and enhances access for device manufacturers to the EU market.
In Oslo, Norway, on May 8, 2025, DNV was officially recognized by the European Commission as a notified body for the certification of in vitro diagnostic (IVD) devices. This recognition is pivotal as it enhances the capacity for certifying IVDs and opens up access for manufacturers aiming to enter the European Union market. The IVDR, introduced in 2017, replaces the older In Vitro Diagnostic Directive and aims to establish a more stringent regulatory framework to ensure the safety and effectiveness of diagnostic devices. A certificate confirming compliance with the IVDR will be required for most IVDs sold in the EU beginning with May 2025 for Class D devices, followed by other classes in subsequent years. DNV's new status enables a fully digital certification process, allowing manufacturers to manage documentation and track compliance online, promoting efficiency and transparency in accessing the EU market. Cecilie Gudesen Torp, Global Director of Medical Services at DNV, expressed their eagerness to support manufacturers of all IVD classes with their certification needs, showcasing DNV's rank among the top five notified bodies for medical device certification along with their extensive expertise in the field.