A device that is assessed in a clinical investigation.
Note: An investigational device can be a non-CE marked device or a CE marked device. The definition in MDR Article 2(46) does not differentiate between different regulatory statuses of devices. However, the reporting requirements are different depending on whether the clinical investigation is done for purposes described in Article 62, 74 or 82. The definition is understood to cover also the devices investigated in PMCF investigations, even if they are not subject to notification per Art 74.1.
[Definition of the term according to MDCG 2020-10/1, also corresponds to definition under (EU) 2017/746 Article 2 No. 46]