Post-Market Success under IVDR: Prioritizing PMS & PMPF
As the IVD industry undergoes significant regulatory changes with the implementation of Regulation (EU) 2017/746 (IVDR), manufacturers are facing new challenges and requirements regarding post-market surveillance (PMS) and post-market performance follow-up (PMPF). In this article, we explore the importance of prioritizing PMS and PMPF under the framework of the IVDR.