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Glossary

Abnormal Use

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Act or omission of an act by the operator or user of a medical device as a result of conduct which is beyond any means of risk control by the manufacturer. 

Other glossary definitions

O

Occupational exposure to a medicinal product

For the purpose of reporting cases of suspected adverse reactions, an exposure to a medicinal…

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I

In Vitro Diagnostic Medical Device (IVDMD)

Any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus,…

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