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Glossary

Trend reporting

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A reporting type used by the manufacturer when a significant increase in events not normally considered to be incidents occurred and for which pre-defined trigger levels are used to determine the threshold for reporting. 

Other glossary definitions

M

Medical Device (MDR definition)

Any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer…

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A

Adverse Device Effect (ADE)

An adverse event related to the use of a medical device. This definition includes any…

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