New more sensitive diagnostics protect transplanted kidney
With new more sensitive diagnostics, rejection of a transplanted kidney can be detected earlier,...
The new In Vitro Diagnostic Devices Regulation (IVDR) places greater emphasis on risk classification and performance evaluation on medical devices. Here, you will find useful information about IVDR and how we can help your laboratory be IVDR compliant.
Cost-effective solution
IVDR-certified test kits are often more cost-effective than alternative solutions, such as developing your own in-house LDTs. By choosing an IVDR-certified product, you can save time and resources while still receiving the highest-quality results.
Increased efficiency
IVDR-certified test kits are designed to be user-friendly and efficient, saving you time and resources in your laboratory operations and improving patient outcomes.
Compliance with regulations
With the implementation of the IVDR, buying IVDR-certified test kits is essential for compliance with European Union regulations. By purchasing from a trusted provider, you can be confident that you are meeting all the necessary requirements and avoiding costly penalties.
At the end of the day, it is all about ensuring safety and accuracy for patients.
What are the main differences between IVDR and IVDD?
Are in-house devices, or laboratory-developed tests (LDTs) under the scope of IVDR?
Yes. Previously, the IVDD did not cover in-house devices or LDTs. Under IVDR, rules for the use and manufacturing of in-house devices are in place.
The In Vitro Diagnostic Regulation (IVDR) was adopted by the European Union (EU) in 2017 and replaced the current In Vitro Diagnostic Directive (IVDD) on May 26, 2022. The transition to the new regulation requires manufacturers to comply with stricter requirements for the safety and performance of in vitro diagnostic devices (IVDs) and to obtain new or updated certifications. To help navigate the IVDR transition process, we've created timelines outlining the key milestones and deadlines. These timelines provide valuable guidance on the necessary steps to ensure compliance with the new regulation.
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