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  • Data relating to certificates issued, modified, supplemented, suspended, withdrawn or refused, 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

D

Device User Facility

A hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, or outpatient treatment facility as…

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D

Disease Risk-factor Reduction Claims (RDRC)

Possibly the highest level of medicine-like health claim that can be made on a non-drug…

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