IVDR Certification with DNV – EU Notified Body #2460
Gain EU market access for your in vitro diagnostic devices with DNV, a designated Notified Body under the In Vitro Diagnostic Regulation (IVDR – EU 2017/746)
IVDR Certification with DNV – EU Notified Body #2460
Who we are
DNV is a designated EU Notified Body for IVDR. This authorization from European regulators allows us to carry out conformity assessments and issue IVDR certificates – a legal requirement for placing IVD devices on the EU market.
What is IVDR certification?
The In Vitro Diagnostic Medical Device Regulation (IVDR – EU 2017/746) is the European Union’s updated regulatory framework for IVD medical devices. It replaces the IVDD (98/79/EC) and introduces stricter requirements around:
- Product safety and performance evidence.
- Clinical evaluation and performance studies.
- Post-market surveillance and vigilance.
Manufacturers must now demonstrate compliance through more robust conformity assessments, and many devices that were previously self-certified under IVDD now require evaluation by a Notified Body like DNV.
Our IVDR certification services
As an IVDR Notified Body, DNV conducts conformity assessments and certification activities, including:
Why choose DNV as your Notified Body?
With decades of experience in medical device conformity assessment, scientific expertise, and a global footprint, DNV supports you in navigating complex IVDR requirements with confidence.
What sets us apart:
- Officially designated as an EU Notified Body for IVDR and MDR
- Trusted Notified Body with international recognition.
- Responsive support with efficient review cycles.
- Alignment with ISO 13485 and MDSAP and risk-based QMS approaches.
- International recognition with local presence
- Independent, science-backed, and collaborative approach.
- Fully digital certification process and manufacturers will be able to manage certification documents online and track compliance status in real time via a secure digital platform, for faster certification with greater transparency.
Resources to support your IVDR journey
Access essential resources and practical guidance to help ensure compliance with the EU In Vitro Diagnostic Regulation (IVDR) and support your certification journey.
Navigating IVDR compliance: Practical insights and strategies for long-term success
Gain practical insights and expert strategies to achieve and maintain IVDR compliance. Join DNV’s live webinar for IVD manufacturers.
Want to secure EU market access and build trust with every test?
Download the IVDR Compliance Guide
Switch your certification to DNV
A designated EU Notified Body for IVDR and MDR
Medical Device Certification
Ensuring safety, compliance, and trust across the medical device lifecycle
