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post market surveillance | MDR | IVDR | PSUR periodic safety update report

Overcoming the Most Common Periodic Safety Update Report (PSUR) and Post-Market Surveillance (PMS) Report Challenges

— coauthored by Jan Kloiber, Senior Principal Specialist and Celeste Maksim, Chief of Staff, Clinical and Post-Market Services May 2022 is the one-year milestone for EU MDR and the date of application for IVDR. For medical devices that have already been approved under MDR, annual periodic safety update reports (PSURs) are due for Class IIb and III devices. Since this is the first year and there is still no official guidance, many manufacturers are struggling with meeting the new regulatory requirements.
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MDR | IVDR

Top 10 Tips on How to Write a PMS Report and PSUR Without an Official Guidance Document

Manufacturers have relied on guidance from the Medical Device Coordination Group and similar organizations to interpret many of the new regulations under EU MDR and IVDR. However, guidance has not been provided for every aspect of the regulation, and application deadlines have not shifted, leaving manufacturers struggling to understand precisely how to be compliant.
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