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Glossary

GMDN – Global Medical Device Nomenclature.

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GMDN is a comprehensive set of terms that provides generic descriptors for the identification of all medical device products, comprised of a Term Name, a (numerical) Code and a Definition. GMDN is used for: 

  • Data exchange between healthcare stakeholders including manufacturers and regulators 
  • Post-market Device safety 
  • Supply chain organisation. 

Other glossary definitions

C

Clinical Trial Application (CTA)

The conduct of clinical trials is subject to prior authorization from health authorities, to ensure…

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I

Informed Consent Form (ICF)

Patients, and/or in specific circumstances their legally designated representative(s), are requested to give written consent…

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