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Periodic Summary Reporting

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Alternative reporting regime that is agreed between the manufacturer and the National Competent Authority for reporting similar incidents with the same device or device type in a consolidated way where the root cause is known or an FSCA has been implemented. 

Other glossary definitions


Health Economic Model

A logical mathematical framework demonstrating the quantitative relationship between a defined set of variables (e.g.…

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Acceptance Criteria

Numerical limits, ranges, or other suitable measures for acceptance of the results of analytical procedures…

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