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 that are being tested are more commonly referred to as investigators. An investigational medical device can therefore be a medical device that has not yet been placed on the market, which may or may not already bear the CE marking, and which is evaluated within or outside its intended purpose. The term is defined in the EU MDR 2017/745 and in Germany in the MPDG.

Medical devices without an intended medical purpose are currently (12/2023) not yet subject to the MDR. Some test objects 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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