Performance Evaluation Plan is one of the key requirements according to IVDR 2017/746 and it is useful to define the clinical evidence needed to support the safe use of an

For in-vitro diagnostic devices, ISO 23640 plays a key role as it defines the requirements related to the stability of in-vitro diagnostic reagents used within an IVD devices. We have

The IVDR - In vitro Diagnostic Regulation 2017/746 - will enter into force in 2022 but it is very important to discuss since now the changes that this new regulation

One of the biggest changes introduced with the new IVDR 2017/746 is the classification for IVD products. In fact the classification substantially changes between IVDD and IVDR in order to

Clinical performance studies for In-Vitro Diagnostic devices are needed when analytical performance studies or other methods like literature research are not sufficient to evaluate the performance of the IVD device.