IVDR taken on together●

The new In Vitro Diagnostics Regulation (IVDR)

The In Vitro Diagnostics Regulation (IVDR) is the new regulatory framework which will affect all in vitro diagnostic medical devices on the European market.

The IVDR (Regulation (EU) 2017/746) replaces the current EU Directive on in vitro diagnostic devices (IVDD 98/79/EC) and applies from May 26th 2022. There is no way to automatically transfer old IVDD classified devices over to the new IVDR, all IVDs must be transitioned to the new regulations’ requirements.

What does this In Vitro Diagnostics Regulation (IVDR) mean for manufacturers and for the users of medical devices? Learn what you need to know about IVDR and its consequences.

What you need to know to embrace the IVDR

Under the new In Vitro Diagnostics Regulation (IVDR), new and all currently approved in vitro diagnostic devices must demonstrate compliance with the new requirements.

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IVDR in the clinic

The market will change with IVDR implementation and so will the range of products. This could significantly affect supply for clinical labs and disrupt their daily operation.

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Leading the debate in LDT

Key speakers are representing different perspectives on recent regulatory landscape for LDTs in the US and Europe under IVDR.

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IVDR at Tecan

As an early adopter of IVDR, Tecan achieved a high level of expertise in IVDR requirements and already received IVDR certification for multiple products. Now we are ready to share gained experience by answering the most frequently asked questions.

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