Our article in the Biotechnologia.pl quarterly

We recommend the latest issue of the quarterly Biotechnologia.pl, which features an article prepared by MDR Regulator and Pure Clinical experts Adrianna Pyrzanowska, Izabela Chodare and Antonina Bartosik. The authors focused on the new requirements for performance testing of in vitro diagnostic medical devices and how to report and supervise testing.

As an encouragement, a small excerpt from the article: “Compared to the IVDD, the IVDR Regulation introduces stringent requirements for the collection and analysis of clinical evidence, which are more stringent the higher the device class. Regulation 2017/746 (IVDR) also requires manufacturers to prepare and submit a performance evaluation of in vitro diagnostic medical devices to demonstrate their safety and performance for the intended use of the device assigned by the manufacturer. The IVDR regulation places great emphasis on the need to update the performance evaluation throughout the life cycle of the device, based on the need to observe the device’s post-market performance. The intent of these changes is to introduce more effective regulatory control to enhance patient safety and health protection.”

We encourage you to read the entire article.

At the same time, we are very pleased to announce that, as part of the cooperation, MDR Regulator and Pure Clinical experts periodically publish in the quarterly magazine.