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In Vitro Diagnostic Regulation
(IVDR) - Our commitment

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.

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How can we help your lab?

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.

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Frequently asked questions

What are the main differences between IVDR and IVDD?
  • IVDR places greater emphasis on risk classification and performance evaluation of in vitro diagnostic devices compared to IVDD.
  • IVDR applies to a wider range of in vitro diagnostic devices, including certain software products, whereas IVDD only covered devices that were placed on the market before May 2022.
  • IVDR introduces the requirement for a Notified Body (an organization that certifies the conformity of medical devices) for certain higher-risk devices, whereas this was not a requirement under the IVDD.
  • IVDR requires manufacturers to appoint a designated person responsible for regulatory compliance, whereas this was not a requirement under the IVDD.
  • IVDR requires post-market surveillance activities and periodic reporting on performance and adverse events, which was not a requirement under the IVDD.
  • IVDR requires the inclusion of unique device identification (UDI) on the device labeling and in the European database (EUDAMED), while this was not a requirement under the 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.

Devyser IVDR timeline (1)

 

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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Do you have any questions about IVDR?

Get in touch and we can help you with specific questions about IVDR and the Devyser products in your lab

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