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.

Our guest speaker Dr Bart Lubbers will present the implications of this new EU legislation for diagnostic laboratories. He will give an overview of the recent amendment and changes in transitional timelines. Furthermore, he will indicate some available information resources and outline a series of actions that can help laboratories to prepare for the transition.

In a live discussion session, topics specifically related to the clinical flow cytometry field will be explored with the participants.