Periodic Safety Update Reports (PSUR) – EU MDR 2017/745

The Periodic Safety Update Report (PSUR) is a document that encapsulates the entirety of the post-market surveillance (PMS) data from the manufacturer’s device as per the defined PMS plan. While new to the EU MDR, not all devices are required to submit a PSUR. Class I devices do not need a PSUR, in its place will be a PMS report for those low-risk devices.

When the EU MDR was initially being developed, it was known that there would be a greater emphasis on safety throughout the entire life cycle of the device, with post-market surveillance being the focal point of this particular initiative of the MDR. Staying compliant with the new regulations will require Regulatory Affairs teams to adopt new practices and procedures, but at the same time, there are a wealth of benefits to be realized by device manufacturers. Increased post-production data, monitoring, and reporting will allow for early detection of negative effects and easier product improvements when necessary.

For the lifetime of the device under evaluation, the PSURs for the EU should include:

• Rationale and description of any preventive and corrective actions taken e.g. FSCAs
• The main findings of the Post Market Clinical Follow-up
• Conclusions stemming from the benefit-risk determination
• Sales volume and an evaluation of the population that has used the device and other details like the frequency of use

The requirements depend on the classification of the device in question. For device classes IIb and III, the PSUR will be part of the technical documentation outlined in Annexes II and III, with an exception to custom-made devices. This should be done at least annually. For class IIa, manufacturers must produce an updated PSUR when necessary, but at least every two years. Annexes II and III also provide the requirements for the PSUR within the technical documents for these devices as well.

When creating the PSUR for custom-made devices, refer to Section 2 of Annex XIII. For class III devices or implantable devices, manufacturers shall submit PSURs utilizing the electronic system i.e. EUDAMED (details can be found in Article 92) to their notified body conducting the conformity assessment as outlined in Article 52. PSURs and the evaluation by the notified body shall be made available to competent authorities through the electronic system.

With the MDR date of application well behind us, the Notified Bodies have already begun reviewing PSURs for their device manufacturers. While this is new for everyone involved, the Notified Bodies will continue to have a special focus on PSURs. Notified Body PSUR reviews are yet another area that is dependent on the risk class of the device. For Class III and implantable devices, the review will be annual. All Class II devices will undergo their evaluation as part of the surveillance audit. If you still need a Notified Body for EU market access post the EU MDR Date of Application (26th May 2021), you can read further guidance about selecting a Notified Body for the European Market.