DNV joins the IVDR framework as a Notified Body: A new option for IVD manufacturers
Written by: Manuel Mateos CEO and Regulatory Affairs Director, CMC Medical Devices & Drugs S.L.
DNV designated as IVDR Notified Body
The list of IVDR Notified Bodies continues to grow, and as of April 30, 2025, DNV Product Assurance, based in Norway, has officially joined the system. Added to the NANDO database under number NB 2460, DNV becomes the 17th Notified Body designated under Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).
This new designation comes at a strategic time for the IVD industry, as manufacturers face critical deadlines and a complex certification process. The inclusion of DNV increases the capacity for IVDR conformity assessments and offers manufacturers an additional route to CE marking for IVDs.
Why DNV’s designation matters for the IVDR framework
Each new Notified Body is more than a number, it’s a new opportunity for manufacturers to plan their IVDR certification pathway more efficiently.
DNV brings a strong international reputation in certification, risk management, and regulatory compliance. Its entry into the IVDR system provides access to a new, credible partner at a time when Notified Body availability remains limited and the pressure on timelines is growing.
Choosing the right Notified Body for your IVD strategy
Selecting a Notified Body is no longer just a procedural step, it’s a strategic decision. With different timelines, areas of expertise, and capacities, each NB offers distinct advantages. DNV may be the right fit for:
- Manufacturers still seeking their first IVDR certification
- Companies looking for faster timelines or available assessment slots
- Businesses valuing a globally recognized conformity assessment body
In short, DNV offers a fresh option for navigating IVDR compliance with greater flexibility and potentially fewer delays.
A positive development for IVD compliance in the EU
With the 2025 IVDR deadlines approaching—especially for Class D devices and legacy IVDs—every new Notified Body strengthens the European regulatory system and eases the burden on both manufacturers and regulators.
DNV’s designation signals that the system is growing, becoming more resilient, and opening more space for IVD manufacturers to operate strategically.
Need help selecting the right Notified Body or building your IVDR strategy?
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