The Medical Device Coordination Group (MDCG) released an updated guidance on "Classification Rules for In-vitro Diagnostic Medical Devices".
This guidance on in vitro diagnostic devices (IVDs) addresses the classification of these devices and clarifies the rules outlined under Annex VIII of Regulation (EU) 2017/746.
The classification of a device is defined by its intended purpose, as specified by the manufacturer. This covers the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use, in the performance evaluation, or in promotional or sales materials or statements.
In this guidance, manufacturers, notified bodies, and health institutions are provided guidelines on how to classify IVDs before they are placed on the market, made available on the market, or placed into service.
The manufacturer must clearly indicate in the device's accompanying information that the device is intended for a specific purpose mentioned in a particular classification rule.
A robust risk-based classification rule is essential for ensuring that devices are classified correctly in accordance with Annex VIII, since certain requirements of the IVDR are associated directly with device classification.
To know more in detail about the Application of the rules, the IVDR Classification Rules click this LINK.