PSURs

**PSURs (Periodic Safety Update Reports)**

A Periodic Safety Update Report (PSUR) is a regulatory document required under European Union (EU) pharmacovigilance legislation, specifically the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR). It serves as a comprehensive update on the safety profile of a medical device or medicinal product over time, providing detailed information on adverse events, risks, and mitigation strategies.

The PSUR is mandated for all medical devices and medicinal products marketed within the EU, including those that have been on the market for several years. It is submitted periodically, typically every two years, or more frequently if significant safety changes occur. The report must be prepared by the sponsor or manufacturer and reviewed by the relevant national competent authorities and the European Medicines Agency (EMA) in the case of medicinal products.

Key components of a PSUR include:

- A summary of safety data collected since the last PSUR submission.

- An assessment of the safety profile, including the incidence and severity of adverse events.

- Risk management activities and their outcomes.

- Any changes in the device or product design, manufacturing processes, or labeling.

- Updates on post-market surveillance activities and any corrective or preventive actions taken.

The PSUR is an essential tool for ensuring the continuous safety and effectiveness of medical devices and medicinal products. It facilitates communication between manufacturers, healthcare professionals, and regulatory authorities, enabling timely identification and mitigation of risks. Failure to comply with the PSUR requirements can result in regulatory actions, including warnings, fines, or market withdrawal.