Description

The Periodic Safety Update Report (PSUR) is a crucial component of post-market surveillance under the European Union Medical Device Regulation (EU MDR). It serves as a systematic means for manufacturers to evaluate the safety and performance of their medical devices over time. The PSUR provides a comprehensive analysis of any adverse events, complaints, or other safety issues associated with the device, along with an assessment of its overall benefit-risk profile. Compliance with PSUR requirements ensures ongoing monitoring of device safety and efficacy, allowing for timely identification and mitigation of potential risks.