Clinical evidence in IVDR Technical Documentation    

The In-Vitro Diagnostic Regulation EU 2017/746 (IVDR) implements a number of new topics not relevant for the IVDD.

One topic focused on by IVDR is clinical evidence, which now plays a very prominent role in the review of Technical Documentation (TD) of IVDs under the IVDR, also in terms of creating the new role of Clinical Reviewer for IVDs.

Together with the changes from list-based to rule-based classification, which significantly increases the number of IVDs that require a product certificate by a Notified Body, this role is becoming very important for IVD manufacturers. They need to address the requirements defined for clinical evidence in order to identify gaps in TD and close them prior to May 2024, when the transitional period for the IVDR will end.

Our webinar informs you of what TÜV SÜD Product Service regards as the focus of clinical evidence in TD review under the IVDR.

Date and time: Thursday, 5 November 2020, 5:30 pm (CET)

Your speaker: Dr. Thomas Theisen, Department Manager IVD

Registration »