With a certain frequency manufacturers of medical devices of risk classes IIa, IIb and III have to create a PSUR (Periodic Safety Update Report) according to MDR Art. 86 and manufacturers of In-vitro-Diagnostics of risk classes C and D have to create a PSUR according to IVDR Art. 81.  For MDR-/ IVDR-certified devices these PSURs have to be submitted to the Notified Body and will be assessed by it according to the requirements.

MDCG 2022-21 contains comprehensive explanations regarding the content of the PSUR for medical devices.

For MDR-/ IVDR-certified devices for which mdc did not receive a PSUR yet (in consideration of the period of creation), mdc will contact the manufacturers to remind the necessity and deadlines.