Guidance on periodic safety update report according to MDR published
10 January 2023
The Medical Device Coordination Group (MDCG) has published the document MDCG-2022-21 “Guidance on periodic safety update report (PSUR) according to the Regulation (EU) 2017/745 (MDR)”.
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. Manufacturers of class I devices do not have to prepare a PSUR; instead, they should prepare a Post-Market Surveillance Report (PMSR) as detailed in Article 85. The guidance MDCG 2022-21, although not covering PMSR, may provide useful suggestions on how information can be presented.
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. 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 the MDCG 2022-21 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 the MDCG 2022-21 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.