Performance Evaluation Plan according to IVDR 2017/746
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
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
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
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.