The Periodic Safety Update Report (PSUR) has been introduced in Article 86 of the Medical
Device Regulation (MDR) 2017/745. The introduction of the PSUR requirement under the
MDR requires a more consistent, standardized and systematic review of all Post-Market
Surveillance (PMS) data by manufacturers of class IIa, class IIb and class III devices.
The PSUR summarises the results and conclusions of the analysis of the post-market
surveillance data gathered as a result of the Post-Market Surveillance Plan (see section 2.1).
The range of PMS data and level of detail of information examined in a PSUR, the modalities for aggregating and assessing the data or the grouping of devices within the same PSUR will depend mainly on the type of device(s) covered, the time span during which the manufacturer has placed them on the EU market and the post-market experience gained with these devices…
