Periodic Safety Update Report (PSUR) and Post-Market Surveillance report (PMS report)

The MDR and IVDR require either a “Post-Market Surveillance Report” or a “Periodic Safety Update Report” from medical device manufacturers. The Periodic Safety Update Report is abbreviated as “PSUR”, the Post-Market Surveillance reports as “PMS report”. PSUR and PMS report: Regulatory background and objectives The European Commission has significantly increased the requirements for monitoring devices…

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