Manufacturers of class IIa, class IIb, and class III medical devices have to prepare a Period Safety Update Report (PSUR) for each device or group of device. Manufacturers of class I medical devices do not have to prepare a PSUR, but a PMS report instead. With article 86, the Medical Devices Regulation (MDR) introduced this requirement.
In December 2022, the Medical Device Coordination Group (MDCD) published a Oh! It looks like you do not have access to this page.
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