DNV SELECTED TO CERTIFY CLASS D DEVICES FOR LEADING U.S. MANUFACTURER UNDER EU IVDR

DNV supports the manufacturer's transition to new regulation with its digital certification platform and transparent, predictable project management.

OSLO, Norway, March 31, 2026 /PRNewswire/ -- DNV, a designated Notified Body for the European Union's In Vitro Diagnostic Regulation (IVDR) and Medical Device Regulation (MDR), has been selected by a leading U.S. diagnostics manufacturer to certify near-patient diagnostic devices under the IVDR.

The engagement covers several families of Class D diagnostic devices, the highest-risk category under the IVDR. These include tests used to detect life-threatening diseases with a high risk of propagation requiring the most stringent regulatory oversight before entering the European market.

As manufacturers transition legacy devices to the IVDR, securing notified body capacity has become a critical step in maintaining access to the European market.

The IVDR, introduced in 2017 to replace the In Vitro Diagnostic 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 as a Notified Body under the IVDR in May 2025. With decades of experience in medical device certification, DNV supports manufacturers worldwide in navigating complex regulatory requirements and maintaining access to international markets.

The manufacturer already has an established working relationship with DNV, having previously certified several devices under other regulatory frameworks, including the multi-national Medical Device Single Audit Program (MDSAP).

The IVDR certification activities are being conducted through DNV's digital certification platform, which allows manufacturers to upload and manage technical and performance documentation within a secure environment. The platform also facilitates efficient collaboration during the review process, helping streamline workflows and improve transparency.

"Having worked extensively with DNV on other certification schemes, we were confident in their expertise and collaborative approach. Their flexible project management and willingness to tailor certification timelines made them a natural partner for our IVDR certification. Their support on post-certification processes is also helping smooth our transition to the new regulation," said a representative of the manufacturer.

"We are proud to support this manufacturer in achieving IVDR certification and maintaining access to the European market," said Cecilie Gudesen Torp, VP and Managing Director, 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 documentation management and communication."

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Learn more at https://www.dnv.com/medical-devices/  

 

source: DNV