In vitro diagnostic medical devices (IVD) are products for testing of human samples (such as salvia, blood, urine, feces or tissues) outside the body to provide information on a person’s health or physiological state. Until 2017 IVDs were regulated by the Directive 98/79/EC on in vitro diagnostic medical devices (IVDD). In May 2017, the new Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) came into force.
The IVDD-to-IVDR transition period will end in May 2022, and there will be a further grace period for certain devices until May 2024.
What does this mean for your IVD, especially for your device for self-testing? Learn about the upcoming changes by attending our webinar – Get ready for IVDR!
Dr. Solveigh Krusekopf is Senior Consultant in the Consulting & Strategic Innovation team at analyze & realize.