![]() MDR and IVDR require manufacturers to collect post-market surveillance data (ie., feedback and information about similar devices) both reactively and proactively. Requirements for post-market reporting under MDR/IVDR are more stringent and comprehensive than they were under MDD/IVDD. ![]() PSUR/PMS Report Requirements Under MDR/IVDR In the meantime, manufacturers must make their best efforts to conform to the regulatory requirements. The regulation gives a vague idea of the expectations but not specific details. Official MDCG Guidance will provide more details on what needs to be in the PSUR or post-market surveillance (PMS) report. Since this is the first year and there is still no official guidance, many manufacturers are struggling with meeting the new regulatory requirements. For medical devices that have already been approved under MDR, annual periodic safety update reports (PSURs) are due for Class IIb and III devices. ![]() May 2022 is the one-year milestone for EU MDR and the date of application for IVDR. ![]()
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