Risk classification and the IVDR: an introduction

The IVDR risk classification system will improve patient safety

The new system of risk classification of IVD medical devices is one of the few radical changes brought about by the new medical device regulations. It is an improvement on the current directive. It aligns the classification of IVD medical devices with other medical devices and international practice as advocated by the Global Harmonization Task Force (GHTF). It is also a more comprehensive approach than the one in the current directive thus enabling an easier application to new IVD medical devices.

However, it also subjects most IVD medical devices to certification by notified bodies. This will improve patient safety. Nevertheless, the complex requirements and scrutiny by notified bodies will have a serious impact on the manufacturers of these products. Many may disappear from the European market as a result. The classification is essentially based on the intended purpose so the emphasis on proving a classification claim is likely to be on being able to prove performance. Some of the rules also introduce the concept of the severity of harm (e.g. likelihood of death in Rule 3(c)). Therefore, determining the applicable rule may require consideration of the clinical impact on the patient. Such an assessment is likely to require the opinion of clinical experts.

Problems of interpretation are less likely to arise for classification criteria that are very specific, e.g. determination of ABO system markers. More general terms such as ’life-threatening’ may result in more issues of interpretation arising. Because many IVD medical devices have not been subject to notified body scrutiny before, it is possible that issues of interpretation of classification rules may arise very quickly. Manufacturers need to be vigilant and monitor how such problems of interpretation will be resolved through guidance and specific decisions.

This is an excerpt from the BSI medical devices white paper: Explaining IVD classification issues. To browse our collection of medical device white papers, please visit the Insight page on the Compliance Navigator website.