Impact of the new IVDR regulation on medical laboratories
“Quick action is necessary”, says an article on the effects of the IVDR regulation on medical laboratories by Dipl. Biol. Ulrich Hafen in edition 3/2019 of the journal Trillium Diagnostik. Medical laboratories that use their own “laboratory developed tests” (LDT), including their own software, are just as affected by the new IVDR regulation, which [...]