The Periodic Safety Update Report is one of two new post-market reports that medical device manufacturers must keep and submit to their Notified Body (NB) regularly. This data supports competent authorities and Notified Body in determining the risk-benefit ratio of the device in compliance with EU 2017/745 CE Marking. The information acquired through these reports helps both patients and healthcare providers stay up to date. The Periodic Safety Update Report is intended to improve medical devices and their advantages to patients.
A Post Market Surveillance Report is required for all devices. The device class’s risk level specifies the type of report, and whether it must be evaluated by a notified body. Low-risk device manufacturers are not required to submit a PSUR, but they must keep a PMSR and make it available to responsible authorities. The Post Market Surveillance Report must include evidence and a description of any corrective actions taken, as well as a summary of the outcomes and conclusions of post-market surveillance (PMS) data.
According to EU MDR article 86, the Periodic Safety Update Report must be provided by manufacturers of medium and high-risk devices (class IIa, IIb, and III) and it must be prepared for the device’s entire lifetime once it has been released to the market. PSURs for high-risk devices must be updated on an annual basis. This is applicable even if the certification is valid for two years. PSURs for Class III devices must also be submitted to Notified Bodies electronically such as EUDAMED. For all other classes, the PSUR must be made available to Notified Bodies and, upon request, to competent authorities.