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A PMS report is needed for class I medical devices as well as for class A and B in-vitro diagnostic medical devices. The PMS report is used to summarize results and draw conclusions based on the PMS data that are collected using the PMS plan. The PMS report shall be updated when necessary and made available to the competent authority upon request.
A Periodic Safety Update Report (PSUR) is needed for class IIa, class IIb and class III medical devices as well as for class C and class D in-vitro diagnostic medical devices. A separate PSUR is needed for each of your devices (or group of devices, where relevant). The PSUR is used to summarize results and draw conclusions based on the PMS data that are collected using the PMS plan. This includes conclusions on the benefit-risk determination, main findings of the post market clinical follow-up (PMCF), volume of sales, population characteristics (size and usage frequency), etc. The PSUR must be updated at least annually for class IIb and class III medical devices (same as for class C and class D diagnostic devices) and at least every two years for class IIa devices.
At AML Christensen, we have an extensive knowledge about how to develop PMS reports and PSURs that comply with the requirements of the EU Medical Device Regulation (MDR) and in-vitro diagnostic regulation (IVDR). As such, we can create the first PSUR/PMS report for your device and ensure that the report is regularly updated throughout the device’s lifetime.
AML Christensen ApS
Agern Allé 5A
2970 Hoersholm, Denmark
CVR. 41553006
E-mail: anna@amlchristensen.com
Phone: +45 23 67 16 00
Fill out the form and one of our experts will get back to you in 24 hours, or reach out to us directly by emailing info@amlgroup.dk.