The MDCG has issued its 2021-14 Guidance related to assignment of codes to in vitro diagnostic medical devices, which is done by the manufacturer when applying for a Notified Body certification or by the Notified Body (with NB providing the final code assignment).
The Guidance explains the meaning of IVR, IVS, IVT, IVP, IVD codes, how they should be used and gives some examples and provides Specific clarifications linked to individual codes at the end of the document (Pages 8-17).
Image 1: Overview of the different types of codes and a summary of the main characteristics of each of them for the assignment to specific devices and the allocation of resources
Source: MDCG, 2021
The full Guidance can be found in our Library of Documents – IVDR – MDCG!