Post-market clinical follow-up (PMCF) activities are necessary for continuously monitoring the clinical benefits, performance, and safety of medical devices after they have been released on the market. As part of a broader post-market surveillance (PMS) strategy, these activities are crucial...
Caroline Perez
The EU has been working to strengthen its regulations for better patient protection and more effective implementation of the rules for in vitro diagnostic medical devices. As a result, in May 2017, a five-year in vitro diagnostic regulation (IVDR) transition...
The In Vitro Diagnostic Regulation (IVDR) has fundamentally changed how in vitro diagnostics (IVD) are regulated in the EU. As a result, scrutiny for review and documentation has increased substantially, including a dramatic increase in required reviews by notified bodies...