Medical device CE marking

MDCG published guidance on the PSUR under the MDR


The Periodic Safety Update Report (PSUR) has been introduced in Article 86 of the MDR. 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 summarizes the results and conclusions of the analysis of the post-market surveillance data gathered as a result of the Post-Market Surveillance Plan. 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.

The main objective of this guidance document is to assist manufacturers to implement the legal requirements laid down in Article 86 MDR. However, manufacturers should have reasonable time to adapt their quality management systems and sufficient flexibility when they draw up and update a PSUR as long as they can demonstrate that it is in line with Article 86 MDR.

Moreover, PSURs already drawn up or in the process of being prepared when this guidance is published should not be expected to have followed this guidance, as long as those PSURs comply with the legal requirements laid down in Article 86 MDR.

The document can be downloaded in our library

Source: European Commission