Hamburg, 16.11.2020, Dr. Peter Wirthschaft

The European Commission’s Medical Device Coordination Group (MDCG) released its new guidance on the classification of in vitro diagnostics (IVD) devices under the Regulation (EU) 2017/746 (IVDR). The document has been developed by an expert group representing Member State Competent Authorities, commission services, notified bodies and diagnostic industry.
The guidance gives explanations to manufacturers, notified bodies, and health care providers on how to classify IVD devices according to the risk-based classification system of the IVDR. This classification system divides IVD devices in to four classes (A-D) from lowest to highest risk based on their intended purpose and inherent risk profile, which is in contrast to the previous list-based system of the Directive 98/79/EC.
Manufacturers are encouraged to use this guidance for classifying their product before placing it on the market, making it available on the market or putting it into service in the European Union. With examples for each class, the guidance illustrates how prototypical IVD devices may be classified. In particular, examples given for IVD devices used in combination may be helpful to manufacturers of assay/analyzer combinations where the analyzer and its software are intended to run the assay and measure the output.