IVDR Confidence, Built on Experience
Meridian’s proven track record in compliance and reliability ensures your lab is ready for the future of diagnostics.
What is In Vitro Diagnostic Regulation (IVDR)?
The In Vitro Diagnostic Regulation (IVDR) is the current European Union (EU) regulatory framework governing the approval and use of in vitro diagnostic (IVD) medical devices within the EU. It replaces the former In Vitro Diagnostic Directive (IVDD 98/79/EC) and entered into force in May 20221, with a phased transition period for implementation.
IVDR establishes stricter standards for safety, performance, and clinical evidence to ensure high-quality diagnostic devices and enhanced patient protection throughout Europe. Meridian is diligently working to transition applicable products to IVDR in line with applicable transition timelines.
What does IVDR mean for Customers?
IVDR brings important changes that impact manufacturers, laboratories, and healthcare providers. These include:
- Stricter classification of IVD devices based on risk
- Increased scrutiny by Notified Bodies for many more types of tests
- Greater documentation and performance evidence requirements
- Enhanced transparency through the EUDAMED database
Why Meridian?
Decades of Regulatory Experience
Under the former In Vitro Diagnostic Directive (IVDD), certain IVD products could be placed on the market through self-certification with limited documentation and performance evidence requirements.
Under IVDR, significantly more rigorous standards apply. Meridian is actively working to transition and certify applicable products under IVDR through the appropriate conformity assessment routes, including Notified Body involvement where required. This approach supports robust clinical and performance evidence, transparent technical documentation, and confidence in the regulatory status of our products.
By choosing Meridian, customers partner with an organization committed to quality, regulatory transparency, and navigating the evolving European regulatory landscape.
Decades of regulatory expertise certified under ISO 13485
Transparent documentation and support
Consistent manufacturing quality across global sites
Direct support from regulatory affairs and product teams
Support & Documents
References
FAQs:
What is IVDR?
IVDR stands for In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746. It’s a European Union regulation that governs the approval, manufacture, marketing, and monitoring of in vitro diagnostic (IVD) medical devices within the EU.
Why was IVDR introduced?
IVDR establishes stricter standards for safety, performance, and clinical evidence to ensure high-quality diagnostics and enhanced patient protection throughout Europe. It replaces the older IVDD (In Vitro Diagnostic Directive 98/79/EC) and introduces stricter and more consistent regulatory standards.
What types of devices are covered under IVDR?
IVDR applies to all in vitro diagnostic medical devices, including but not limited to:
- Immunoassays
- Molecular diagnostics
- Serological tests
- Urinalysis kits
- Instrumentation & software
- Specimen collection containers
Meridian can Help
Meridian provides information and support to help you navigate IVDR requirements.