#USA #Medical Devices #Oslo #DNV Certification #IVDR Regulatory

DNV Selected to Certify Class D Devices for a Leading US Manufacturer

In a significant development, DNV has been appointed as the certifying body for Class D diagnostic devices produced by a prominent manufacturer in the United States. This strategic collaboration comes amidst the stringent regulations laid out by the European Union's In Vitro Diagnostic Regulation (IVDR). With DNV’s designated status, the manufacturer is poised to navigate the complex compliance requirements essential for accessing the European market.

The IVDR, which came into effect in May 2025, is aimed at enhancing the safety and efficacy of in vitro diagnostic devices. Class D devices, being categorized as the highest risk according to the regulation, include tests essential for detecting critical and potentially life-threatening conditions. This necessitates rigorous regulatory oversight before these products can be introduced to the EU market.

DNV’s role in this certification process is pivotal, as it not only ensures compliance with the IVDR but also supports manufacturers in transitioning their existing products to meet these new requirements. The partnership underscores DNV’s extensive experience in certification, which has been honed over decades in the medical device industry.

The selected manufacturer has a pre-established relationship with DNV, having previously certified various devices under multiple regulatory frameworks, including the Medical Device Single Audit Program (MDSAP). This existing relationship allows for a smoother transition into the IVDR certification process.

Additionally, the certification activities will be carried out using DNV’s digital certification platform. This innovative tool allows manufacturers to securely upload and manage important technical and performance documents, fostering collaboration and enhancing transparency during the review process. The platform streamlines workflows and elevates operational efficiency, which is vital given the complexities involved in regulatory compliance.

A representative from the manufacturer expressed confidence in DNV’s capabilities, stating, "Having collaborated extensively with DNV on previous certifications, we are assured of their thorough understanding of our needs and their flexible approach in managing timelines. Their support in post-certification processes is invaluable as we adapt to the new regulations."

Cecilie Gudesen Torp, Vice President and General Manager of Medical Technologies at DNV, reinforced the company’s commitment, saying, "We are honored to support this leading US manufacturer in achieving IVDR certification. Our aim is to facilitate a certification process that is efficient, transparent, and collaborative, combining digital project management with user-friendly documentation tools to ease communication."

As the medical device landscape evolves with increasing regulatory demands, DNV is well-positioned to assist manufacturers in ensuring their products meet new compliance standards. This collaborative effort between DNV and the US manufacturer could serve as a model for others in the industry looking to navigate the complexities of the IVDR efficiently and effectively.

For more information, visit DNV’s website.