The impact of the new European IVD-classification rules on the notified body involvement; : a study on the IVDs registered in the Netherlands :

In vitro diagnostics (IVDs) are medical devices for carrying out a test using human specimens such as urine or blood. Examples of these products are pregnancy tests, tests for determining the level of glucose or cholesterol in the blood, and tests that determine the blood group. 

To ensure that these products are safe and effective in use, the manufacturers must go through a procedure before the IVDs may be sold. The current legislation contains two lists on which IVDs are subdivided into a medium-risk and a high-risk category. IVDs that are not on these lists are automatically classified as low risk. An example of an IVD with high risk is an HIV test, whereas a blood collection tube or a pregnancy test has a low risk. A more stringent market authorisation procedure applies for IVDs with a high risk level and additional approval by an external party, a so-called notified body, is required. For low-risk IVDs, manufacturers may carry out the licensing procedure themselves. 

This system with lists is no longer sufficient. It has therefore been changed in the new European legislation for IVDs, which comes into effect in 2022. The risk of IVDs is then determined according to rules and subdivided into a cascade of four categories. Examples of factors that determine the risk are severity of the disorder tested for and possible consequences of an incorrect test result. Research carried out by the National Institute for Public Health and the Environment (RIVM) has shown that this means that many more IVDs will end up in a higher risk category (84 instead of 7 percent). This means that the number of IVDs for which the manufacturer requires approval of a notified body in order to obtain market authorization will be much greater. 

This study was carried out by the order of the Dutch Health and Youth Care Inspectorate (IGJ). 



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