# DNV to Certify Class D Devices for U.S. Manufacturer Under EU IVDR
DNV has been selected to provide classification services for Class D in vitro diagnostic devices under the European Union’s In Vitro Diagnostic Regulation (IVDR), supporting a leading U.S. manufacturer’s regulatory transition. The classification will be facilitated through DNV’s digital certification platform, which the firm says offers transparent and predictable project management throughout the approval process.
The EU IVDR represents a significant regulatory shift from the previous In Vitro Diagnostic Directive, introducing stricter requirements for device classification, technical documentation, and quality management systems. Manufacturers operating in European markets must comply with the new framework, making certification partnerships with recognized notified bodies increasingly critical. DNV’s involvement underscores the growing role of digital solutions in streamlining compliance workflows across regulated industries, including maritime-adjacent sectors that rely on diagnostic and safety equipment.
For the maritime industry, this development is relevant given the sector’s reliance on diagnostic and medical devices for crew health and safety protocols. The modernization of certification processes and digital compliance platforms can enhance efficiency in supply chain documentation and regulatory adherence—standards that equally apply to maritime equipment suppliers and vessel operators navigating complex international regulations. As manufacturers adapt to stricter EU standards, the ripple effects on equipment sourcing and certification timelines may impact maritime procurement strategies.