What is an investigational medical device?

An investigational medical device is a product that is evaluated for its health and safety aspects as part of a clinical investigation.

Medicinal products under evaluation are often referred to as investigational substances. An investigational medical device can therefore be a medical device that has not yet been placed on the market, may or may not bear the CE marking, and is evaluated either within or outside its intended purpose. The term is defined in the EU MDR 2017/745, and in Germany under the Medical Devices Implementation Act (MPDG).

Medical devices without an intended medical purpose are currently (as of 12/2023) not yet subject to the MDR. Some investigational devices cannot be easily and clearly assigned to the categories "medical device" or "medicinal product". In cases of doubt, the categorisation is decided by the authorities. Special legal requirements apply to investigational medical devices.

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