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Glossary

EUDAMED

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The European database for medical devices EUDAMED is to centralize: 

  • Data relating to registration of manufacturers and medical devices placed on the community market, 
  • Data relating to certificates issued, modified, supplemented, suspended, withdrawn or refused, 
  • Data obtained in accordance with the vigilance procedure, 
  • Data concerning clinical investigations. 

Other glossary definitions

I

Investigational Medicinal Product Dossier (IMPD)

Regulators’ review of a Clinical Trial Application (CTA) is, for a part, based on information about the…

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S

Serious (Public) Health Threat

Any event type, which results in an imminent risk to the study population of death,…

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