| Theme | Qualification of IVD |
| Target Audience | Manufacturers, NB |
| Products concerned | IVD |
| Documents mentioned | IVDR (EU) 2017/746 – article 2(2) et 2(4) |
The purpose of this guidance document is to clarify which products fall within the scope of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVD) – also known as qualifying as an IVD or IVD accessory.
It provides non-exhaustive lists of examples of IVD and IVD accessories. The examples are indicative and qualification of specific products should be considered on a case-by-case basis by each manufacturer depending on the intended purpose.