DNV supports the manufacturer’s transition to new regulations with its digital certification platform and transparent and predictable project management.
Oslo, Norway, March 31, 2026 /PRNewswire/ — DNV, a designated notified body for the European Union’s In Vitro Diagnostics Regulation (IVDR) and Medical Device Regulation (MDR), has been selected by a major U.S. diagnostic manufacturer to certify near-patient diagnostic devices under the IVDR.
The commitment covers several families of class D diagnostic devices, the highest risk category according to the IVDR. These include tests used to detect life-threatening diseases with a high risk of spreading and requiring the strictest regulatory oversight before entering the European market.
As manufacturers migrate their legacy devices to IVDR, ensuring notified body capacity has become a crucial step in maintaining access to the European market.
The IVDR, introduced in 2017 to replace the In Vitro Diagnostics Directive 98/79/EC (IVDD), significantly strengthens regulatory requirements for diagnostic devices in Europe, including stricter clinical evidence requirements and expanded involvement of notified bodies.
DNV was designated a Notified Body under the IVDR in May 2025. With decades of experience in medical device certification, DNV helps manufacturers around the world adapt to complex regulatory requirements and maintain access to international markets.
The manufacturer already has an established working relationship with DNV, having already certified several devices under other regulatory frameworks, including the Multinational Medical Device Single Audit Program (MDSAP).
IVDR certification activities are conducted through DNV’s digital certification platform, which allows manufacturers to upload and manage technical and performance documentation in a secure environment. The platform also facilitates effective collaboration during the review process, helping to streamline workflows and improve transparency.
“Having worked extensively with DNV on other certification programs, we were confident in their expertise and collaborative approach. Their flexible project management and willingness to adapt certification deadlines made them a natural partner for our IVDR certification. Their support in post-certification processes also helps smooth our transition to the new regulations,” said a manufacturer representative.
“We are proud to support this manufacturer in achieving IVDR certification and maintaining access to the European market,” said Cecilie Gudesen Torp, vice president and general manager of medical technologies at DNV. “Our goal is to make the certification process as efficient and transparent as possible by combining collaborative project management with digital tools that simplify document management and communication.”
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