IVDR Certification – EU market access for IVD devices
Achieve IVDR compliance with expert support from DNV – a trusted EU Notified Body helping IVD manufacturers reduce risk and ensure certification.
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 for product safety, clinical evidence, and post-market surveillance. Manufacturers must now demonstrate compliance through more robust conformity assessments, often involving a Notified Body.
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.
- Lab instruments, reagents, calibrators.
- OEM/private label manufacturers.
- Importers and distributors operating in the EU.
If your device was previously self-certified under IVDD, you may now need Notified Body involvement under IVDR.
Our IVDR certification services
DNV provides comprehensive support to help you achieve and maintain IVDR compliance. Our services include:
- 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 for IVDR?
We are more than a certification body. With deep medical device experience, scientific expertise, and global reach, DNV is uniquely positioned to help you navigate complex regulations with confidence.
What makes us different:
- Proven track record in IVDR and MDR certifications.
- Trusted Notified Body with international recognition.
- Responsive support with efficient review cycles.
- Alignment with ISO 13485 and MDSAP and risk-based QMS approaches.
- Local presence with global consistency.
- 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.
