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In-house Tests Under EU IVDR – How to Best Meet Your IVDR Deadlines

Learn more about how to do your best to meet the first May 2024 deadline for your in-house test under the EU IVDR.

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THE CONTENT OF THIS WEBINAR IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT INTENDED TO CONVEY LEGAL OR OTHER PROFESSIONAL ADVICE.

Watch now: In-house tests under EU IVDR – How to best meet your IVDR deadlines

In this webinar, our Emergo by UL subject matter expert navigates through current regulatory requirements under IVDR.

Webinar date

Feb. 28, 2024

The In Vitro Diagnostic Medical Devices Regulation (IVDR) (EU) 2017/746 is not only affecting legal manufacturers (companies) but also clinical laboratories using in-house tests. Though not all requirements apply to clinical laboratories, they must maintain technical documentation and update their quality management system to comply with the IVDR and national laws. The amended and phased implementation of the IVDR has set the first deadline to some of these requirements for May 2024.

This webinar will help you get a deeper understanding of the new IVDR requirements for clinical laboratories or parties involved in the manufacture or use of in-house tests. The presenter will explain the required actions in the remaining time (sprint) and share practical examples of how to comply with the IVDR in the long term (marathon).

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European Authorized Representative for Medical Device and IVD Companies

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IVDD to IVDR Gap Analysis Services

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IVDR Resource Center for IVD Manufacturers

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