Investigational medical device

A device already on the market is also investigational when it is studied for a new use, population, material or design change, or in a post-market investigation. In the US the related term is investigational device under 21 CFR 812.

medical device (3.34) being assessed for clinical performance (3.11), effectiveness (3.20), or safety in a clinical investigation (3.8) Note 1 to entry: This includes medical devices already on the market that are being evaluated for new intended uses, new populations, new materials or design changes. Note 2 to entry: This includes medical devices already on the market that are being evaluated within their intended use in a post-market clinical investigation (interventional or non-interventional). Note 3 to entry: For the purpose of this document, the terms “investigational medical device” and “investigational device” are used interchangeably.

ISO 14155:2020, clause 3.29