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Glossary

Expedited Criteria

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Criteria that should be fulfilled for expedited reporting. The four minimum information required for expedited reporting are: an identifiable patient, the name of the suspect medicinal product, an identifiable reporting source, and an event or outcome that can be identified as serious and unexpected.  

Other glossary definitions

C

Competent Authority

Is responsible for the authorization of medicines / medical devices and for ensuring that medicines…

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I

Incident for IVDMD (IVDR definition)

Any malfunction or deterioration in the characteristics or performance of a device made available on…

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