Best of ESCCA session presented by SCS : New IVD-R regulations – how to prepare your diagnostic lab ?

The new IVD-R regulations affect not only the commercial distributors of laboratory assays (as in the past with CE-IVD) but also diagnostic laboratories who use in house-assays (IH-IVD). This talk intends to lay out the timeline for implementation of the IVD-R regulations for diagnostic laboratories and give some orientation how you can prepare your lab by adjusting the validation process of new in-house assays and the implementation of new technologies.