Questions & Answers

The European Regulation on In Vitro Diagnostic Medical Devices 2017/746 (IVDR), being officially 26/05/2022, is approaching fast. In flow cytometry, only the minority of tests have received the new CE-IVD label required to be sold on the European market, and there are not enough notified bodies recognized to provide certificates. Our Belgian IVDR work group recently informed us that a proposal is being made on European level to prolong the transition period with 3 to 5 years, depending on the risk class of existing commercial in vitro diagnostic (IVD) medical devices. The following deadlines were recently communicated: Current products with CE-IVD label à 26/05/2025; LDTs: documentation and inspection à 26/05/2024; LDTs: justification in case required à 26/05/2028. Meanwhile, we are curious how you deal with these challenges and what your opinion is on how a LDT test should be defined and which changes are critical. During February and March, you can leave your questions regarding IVDR and flow cytometry here, and an expert in IVD-R (prof. dr. Pieter Vermeersch, UZL) will take the time to answer them. Go to the Q&A IVDR section on this website, and ask your questions now!