Glossary · EU medical devices: MDR

Periodic safety update report (PSUR)

Also known as: PSUR

Under the EU Medical Device Regulation (EU) 2017/745 and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746, the periodic safety update report is the document in which manufacturers of class IIa, IIb and III medical devices and of class C and D IVDs summarize the results and conclusions of their post-market surveillance data, with the rationale for and description of any preventive and corrective actions taken.

EU
MDR
IVDR
Technical documentation

In one sentence

The PSUR (MDR Art. 86, IVDR Art. 81) summarizes post-market surveillance results for class IIa–III devices and class C and D IVDs at fixed intervals.

Example

A manufacturer of a class III implantable defibrillator uploads its annual PSUR to EUDAMED; the notified body reviews it, adds its evaluation, and the manufacturer updates the SSCP with the new PMCF findings.

How it applies

Frequency: Class IIa devices at least every two years; class IIb and class III devices at least annually. Under the IVDR, class C and D devices at least annually.
Content: The conclusions of the benefit-risk determination, the main findings of PMCF or PMPF, and the sales volume with an estimate of the size and characteristics of the population using the device.
Submission: For class III and implantable devices, and for class D IVDs, the PSUR goes to the notified body through EUDAMED; the notified body adds its evaluation. For other classes it is made available to the notified body and, on request, to competent authorities. Check which EUDAMED modules are mandatory.
Guidance: MDCG 2022-21 describes the structure, data periods and presentation that notified bodies expect.
Technical documentation: The PSUR is part of the technical documentation on post-market surveillance (Annex III). Its conclusions must match the risk file, clinical or performance evaluation and labeling.

PSUR vs. PMS report

The PSUR applies to the higher classes and has a fixed minimum update cycle. Class I medical devices and class A and B IVDs produce a PMS report instead, updated when necessary. The medicinal product PSUR under pharmacovigilance (GVP) is a different document with its own legal basis, even though the name is the same.