The European Commission just published an advice on IVDs testing SARS-CoV-2 on request from the Medical Device Coordination Group (MDCG) issued by the IVDR Expert Panel from the European Medicines Agency (EMA). The document provides guidance on the classification and risk assessment of in vitro diagnostic (IVD) devices intended for the detection of SARS-CoV-2 and its neutralising antibodies. The MDCG requested the advise of the following topics:
- SARS-CoV-2 as causing a life-threatening disease
- SARS-CoV-2 considered to be of high or suspected high risk of propagation
- Risks of erroneous results of a device intended to detect SARS-CoV-2
- Risks of erroneous results of a device intended to detect antibodies against SARS-CoV-2
Advice on SARS-CoV-2
SARS-CoV-2 was initially considered a life-threatening respiratory disease due to high transmission rates and severe complications in certain populations (elderly, immunocompromised, and individuals with underlying conditions) as well as its global impact. During the pandemic, genetic mutations led to the emergence of variants like Alpha, Beta, Gamma, Delta, and eventually Omicron, which became the dominant variant. Epidemiological data show a decrease in COVID-19-related deaths after May 2022, indicating that SARS-CoV-2 no longer causes a life-threatening disease with significant mortality level in the general population. However, high-risk groups remain vulnerable to the COVID-19 disease and SARS-CoV-2 remains a highly transmissible and persistent virus.
Furthermore, the Expert panel advises that erroneous SARS-CoV-2 test results (false positives or false negatives) generally do not cause severe disability or death in the general population. Nonetheless, among vulnerable groups timely diagnosis remains important and the consequences of an erroneous result can be more severe. On the other hand, antibody detection is not a diagnostic tool for identifying an active infection and the risk of an erroneous antibody test result leading to a life-threatening situation is considered low.
Reclassification of Covid-19 tests
Although sometimes used interchangeably, it is important to note that the tests are used to detect the virus infection (SARS-CoV-2) and not the disease caused by this virus (COVID-19).
The MDCG guidance on IVD classification (MDCG 2020-16) is being updated to reflect the new advice. It is important to note that the expert panel’s advice and the MDCG classification guidance are not legally binding. Each device’s risk classification should be determined on a case-by-case basis by the manufacturer, considering the device’s intended purpose and target population. Additionally, the panel’s advice pertains to the current epidemiological context, and manufacturers should consider any changes in this context when evaluating the classification of their tests.
The possible reclassification of tests will impact the legacy extension periods for manufacturers. Currently classified as class D under IVDR, manufacturers of legacy COVID-19 tests can place their IVDs on the market until 31 December 2027 if the legacy provisions are met. A change to the classification under IVDR would lead to a prolonged transitional period if certain conditions are met.
Do you have questions on how to place IVDs on the EU and UK market? Contact us here or at mdlaw@obelis.net.
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