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CATEGORY: CLINICAL
Investigational Device
A medical device that is the subject of a clinical investigation. In the US, an Investigational Device Exemption (IDE) allows the device to be used in a clinical study. Under EU MDR, investigational devices follow Article 62-82.
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · 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
- Determine IDE (US) or clinical investigation notification/approval (EU MDR Art. 62+) requirements.
- Secure ethics/IRB approvals, informed consent, and monitoring plans.
- Manufacture under investigational controls; label “investigational use”.
- 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
Track regulatory signals related to Investigational Device across 27 authorities in real time.
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