The MDCG has recently published a guidance concerning the qualification of in vitro diagnostic medical devices. The purpose of this guidance document is to clarify what products fall in scope of Regulation 2017/746 on in vitro diagnostic medical devices (IVDR) or an accessory to an IVD.
For a product to qualify as an IVD or an IVD accessory, it must meet the respective definitions outlined in Article 2(2) or Article 2(4) of the IVDR. The qualification process is largely determined by the product’s intended purpose, as specified by the manufacturer.
A clear distinction between the IVDR and Regulation (EU) 2017/745 on medical devices (MDR) is crucial, particularly since MDR explicitly states in Article 1 that it does not apply to in vitro diagnostic medical devices. Understanding the boundary between these two regulations ensures that manufacturers correctly categorize their products under the appropriate regulatory framework.
This guidance document includes non-exhaustive lists of examples of IVDs and accessories to IVDs. It is important to note that the examples provided in this guidance are indicative, and the qualification of specific products should be assessed individually by the manufacturer, based on the product’s intended purpose. This means that even products detecting or measuring the same analyte might be classified differently, depending on the intended purposes assigned by each manufacturer. Therefore, the qualification process is highly context-specific and should take into account the particular use and claims made for each product.
The guidance can be accessed using the following link
