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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  • Data relating to certificates issued, modified, supplemented, suspended, withdrawn or refused, 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. 

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C

Compassionate Use

The use of an unauthorised medicine outside a clinical study in individual patients under strictly…

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N

New Chemical Entity (NCE)

A New Chemical Entity (NCE) is a compound, without any precedent among the regulated and…

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