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The IVDR and transitional timelines - implications for clinical flow cytometry laboratories
The IVDR (Regulation (EU) 2017/746 on in vitro diagnostic medical devices) will have major consequences for the diagnostic sector, and especially for flow cytometry laboratories that perform in-house tests (also known as Laboratory Developed Tests, or LDTs).
Although the recent amendment does not alter any of the requirements of the regulation, it does change the date upon which some requirements will come into effect for certain IVD assays, including LDTs. Understanding these changes and preparing accordingly will be key to safeguarding the continuity of diagnostic services in laboratories.
Course target group
This webinar is recommended for lab managers, lab technicians, quality officers and quality managers.