Periodic Safety Update Report FAQ
What is a Periodic Safety Update Report (PSUR)?
Which devices require one? What are the requirements?
We have the answers and more…
Periodic safety update report
CER, SSCP and PSUR
What’s the difference between CER, SSCP, and PSUR? Clin-r+ provides a break-down of the aspiration and content of each report, and explains why the reports are required under the EU MDR.
Periodic Safety Update Report
What is a PSUR? Periodic safety reporting improves medical devices and the advantages they provide to patients. All devices require either a PMSR or PSUR, and the risk associated with the device class determines which report is required, whether it must be reviewed by a notified body (NB), and the frequency of review.
