07 Mar Coronavirus detection kits How would we classify this in vitro medical device according to the new regulation?
Detection kits for Covid-19 virus, the well-known “Wuhan coronavirus”, are medical devices for the diagnosis of the Covid-19 virus. in vitro. Cs such, their placing on the European market is regulated by Regulation 746/2017. This Regulation categorises in vitro medical devices into 4 levels, depending on the risk to the patient, with A being the lowest and D the highest.
These kits are becoming more and more abundant on the market, and at Episkey Medical we have been interested in finding out which of the 4 established risk levels these kits fall into. We have concluded that they would be class D, the highest risk class.
- CLASSIFICATION RULES
2.1. Rule 1
Class D includes goods intended to be used for the following purposes:
– the detection of the presence of, or exposure to, a transmissible agent in blood and blood components, cells, tissues or organs, or derivatives thereof, to assess their suitability for transfusion, transplantation or cell administration;
– the detection of the presence of, or exposure to, a communicable agent causing a life-threatening disease and with a high or suspected high risk of spread;
– the determination of the infectious burden of a life-threatening disease when its observation is essential in the patient management process;
We consider that this type of in vitro medical device falls into this category given that on 30 January 2020, the World Health Organisation’s International Health Regulations Emergency Committee declared the “outbreak a public health emergency of international concern“.
How do these in vitro medical devices work?
According to the US Centers for Disease Control and Prevention (CDC) these kits are critical to improving the ability to detect and respond to coronavirus. Its official name is CDC 2019-nCoV Real Time RT-PCR.
The name refers to the fact that it is a real-time reverse transcriptase-polymerase chain reaction diagnostic panel for the detection of the new 2019 coronavirus and has been developed by the Centers for Disease Control and Prevention”.
This in vitro medical device is a tool that is also used to test for influenza, yellow fever and other diseases by amplifying the nucleic acids present in the sample. In the case of the CDC coronavirus test, it is done for RNA detection using upper and lower respiratory tract samples.
The laboratory test kit developed by CDC to detect 2019-nCoV began shipping on 5 February to select qualified US and international laboratories. Since then, new kits have emerged, the nature of which may determine the number of cases currently being discussed.