DNV Selected to Certify Class D Devices for US Manufacturer Under EU IVDR Regulations

Det Norske Veritas (DNV), a leading global assurance and risk management provider, has been selected to certify Class D in vitro diagnostic (IVD) devices for a prominent US-based manufacturer under the European Union's In Vitro Diagnostic Regulation (IVDR). The certification engagement supports the manufacturer's transition to the new regulatory requirements, which represent a significant shift in how diagnostic devices are approved and managed within the EU market. DNV is providing comprehensive support through its digital certification platform alongside transparent project management to ensure a predictable and efficient certification process. ## Regulatory Context The IVDR, which came into force on February 26, 2022, represents one of the most substantial regulatory changes in the diagnostic testing industry in recent years. The regulation strengthens oversight of in vitro diagnostic devices across the EU and creates a more stringent framework for device classification, quality management, and post-market surveillance. Class D devices—the highest risk category under IVDR—require the most rigorous regulatory pathway, including notified body assessment and conformity procedures. This classification typically applies to devices used for diagnosis of life-threatening conditions or transmissible diseases. ## Digital Certification Platform DNV's selection underscores the critical role of specialized certification expertise as manufacturers navigate increasingly complex regulatory landscapes. The company's digital certification platform enables streamlined documentation management, enhanced traceability, and real-time project visibility—factors essential for managing the extensive technical files and quality documentation required for Class D device approval. The transparent project management approach provided by DNV helps manufacturers anticipate timelines and resource requirements, reducing regulatory uncertainty during the certification process. This is particularly valuable for device makers managing multiple products across different risk classifications simultaneously. ## Market Implications The IVDR transition continues to reshape the in vitro diagnostics industry, particularly for US manufacturers serving the European market. Compliance timelines have created sustained demand for notified body services, and companies like DNV have positioned themselves as strategic partners in managing the regulatory transition. For the broader maritime and offshore sectors that rely on IVD devices for occupational health and safety, the IVDR's stricter requirements ultimately enhance device safety and performance standards across global supply chains. DNV's engagement reflects ongoing confidence in the company's capability to manage complex regulatory certifications while maintaining operational efficiency during the IVDR transition period.