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)
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.
Who needs IVDR certification?
Any manufacturer of in vitro diagnostic (IVD) devices intending to sell within the EU must comply with IVDR. This includes:
- Devices for diagnosis, screening, monitoring.
- Near-patient, self-testing, and companion diagnostic devices.
- Laboratory instruments, reagents, calibrators.
- OEM/private label manufacturers.
- Importers and distributors operating in the EU.
Our IVDR certification services
As an IVDR Notified Body, DNV conducts conformity assessments and certification activities, including:
- Technical documentation review.
- Full conformity assessments (Annex IX, XI).
- Performance evaluation verification.
- QMS integration, ISO 13485 and MDSAP alignment.
- Post-market surveillance system assessment.
- Re-certification and continuous compliance.
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.
