Investigational device

In the US, an investigational device must be labeled as limited to investigational use. A marketed device studied for a new, unapproved use is also an investigational device for that study.

‘investigational device’ means a device that is assessed in a clinical investigation;

EU MDR, Article 2(46)

Investigational device means a device, including a transitional device, that is the object of an investigation.

21 CFR, 812.3

1) An unapproved new device or a currently marketed device being studied for an unapproved use in a clinical investigation or research involving one or more subjects to determine the safety or effectiveness of the device. 2) A device, including a transitional device, that is the object of an investigation, where a Transitional device means a device subject to Section 520(l) of the FD&C Act, that is, a device that FDA considered to be a new drug or an antibiotic drug before May 28, 1976 (See 21 CFR 812.3(g) and (h)).

FDA guidance: Design Considerations for Pivotal Clinical Investigations for Medical Devices (November 2013), Section 11, Glossary

The MDR defines it as a device assessed in a clinical investigation. 21 CFR 812.3 adds transitional devices. The FDA pivotal study guidance also names unapproved devices and marketed devices studied for an unapproved use.