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CATÉGORIE: CLINICAL

Dispositif expérimental

Un dispositif médical faisant l'objet d'une investigation clinique. Aux États-Unis, une IDE permet son utilisation dans une étude clinique.

Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy

Expanded process notes below are currently maintained in English; the short definition above is localized. See our editorial policy.

WHEN IT APPLIES

An investigational device is used in a clinical investigation to evaluate safety/effectiveness before full marketing authorization—or under research exemptions with controls.

PROCESS / STEPS

  1. Determine IDE (US) or clinical investigation notification/approval (EU MDR Art. 62+) requirements.
  2. Secure ethics/IRB approvals, informed consent, and monitoring plans.
  3. Manufacture under investigational controls; label “investigational use”.
  4. Report serious adverse events and manage protocol amendments.

EXAMPLES

  • A novel implant may require an FDA IDE before pivotal trials supporting PMA.

RELATED GUIDES & TOOLS

SOURCES

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TERMES CONNEXES

Investigation cliniqueApprobation pré-commercialisation (PMA)