Reassessment of SARS-CoV-2: Scientific Opinion of the Medical Devices Expert Panel
On 29 January 2025, the Medical Devices Coordination Group (MDCG) published a scientific opinion requested from the European Medicines Agency (EMA) on the classification of SARS-CoV-2 in in vitro diagnostic medical devices (IVDs). This assessment comes four years after the emergence of the virus, at a time when it continues to circulate in the community, albeit with a less severe impact on public health.
Context and Purpose of the Reassessment
Since the pandemic was declared in March 2020, SARS-CoV-2 has been classified as a potentially fatal disease agent with a high risk of spread, resulting in the classification of IVD devices for virus detection in class D, in accordance with MDCG guidance 2020-16. However, with the evolution of the epidemiological situation, the MDCG requested a review to determine whether these criteria are still applicable.
The purpose of this reassessment is to evaluate whether SARS-CoV-2 continues to pose a life-threatening or high risk of spread, impacting the classification of IVD devices under Regulation (EU) 2017/746.
Main Conclusions of the Opinion
Potentially Fatal Disease: Although SARS-CoV-2 can still cause serious illness, especially in at-risk groups (pregnant women, the elderly, and immunocompromised individuals), the opinion concludes that, in the general population, infection is no longer considered a life-threatening disease.
High Risk of Spread: The opinion confirms that SARS-CoV-2 continues to pose a high risk of spread due to its high transmissibility, mutability, and the possibility of new variants emerging that may escape population immunity.
Impact of Erroneous Results on IVD Devices:
For the general population, a false result (positive or negative) is unlikely to cause death or serious disability.
For vulnerable groups (pregnant women, the elderly, or immunocompromised individuals), a false negative result can have serious consequences due to the absence or delay of appropriate treatment.
Neutralising Antibodies: The detection of neutralising antibodies against SARS-CoV-2 has no impact on the clinical management of life-threatening situations.
Implications for the Medical Device Industry
This opinion may influence the reclassification of SARS-CoV-2-related IVD devices, adjusting them to the evolution of the pandemic and the current epidemiological scenario. Companies involved in the development and marketing of IVD devices should closely monitor MDCG guidelines to ensure continued compliance with regulatory requirements.
