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Post Marketing Surveillance report (PMSR)

As per EU MDR and IVDR, PMSR shall be prepared for a class I medical devices & Class A and B in-vitro diagnostic devices, a post-market surveillance report summarizing the results and conclusions of the analyses of the post-market surveillance data gathered as per the post-market surveillance plan.

This PMSR need not be submitted to notifying body during technical file assessment, however must be prepared and updated periodically and shall always be at the disposal of competent authority when requested.

This PMSR shall contain results and conclusion of the analysis of Post Market Surveillance data against the PMS Plan. It should also describe the rationale and description of number of corrective and preventive actions takes against customer complaints and audit observations. It shall clearly state the number of devices sold and observed non-conformities.

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Other than the periodic updates, the PMSR can also be updated if any changes are made to the Class I Medical Device or Class A, B IVDs in scope.

The Post Marketing Surveillance report shall be prepared and updated throughout the lifecycle of medical devices and in-vitro diagnostic medical devices (IVDs).

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