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Glossary

Serious (Public) Health Threat

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Any event type, which results in an imminent risk to the study population of death, serious injury, or serious illness that requires prompt remedial action and that may cause significant morbidity or mortality in humans, or that is unusual or unexpected for the given place and time. 

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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C

Comparative Effectiveness Analysis (CEA)

A systematic evaluation of the evidence on the outcomes of different drugs or other options…

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