Periodic Safety Update Report (PSUR)

“Manufacturers of class [… IIa, IIb, III] devices shall prepare a periodic safety update report (‘PSUR’) […] summarising the results and conclusions […] of the post-market surveillance data gathered […].” (Art. 86, No. 1, EU MDR)

The requirements on the form, content, frequency of updates of the PSUR and if necessary reviews by a notified body are described in Art. 86 EU MDR.

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