The IVD expert panel has provided new scientific advice on SARS-CoV-2. The advice highlights that while the virus can still cause serious illness, it no longer poses a life-threatening risk with a significant mortality rate for the general European population.
This information may affect how SARS-CoV-2 tests are classified under Regulation (EU) 2017/746. Manufacturers are encouraged to assess how this advice impacts their devices and consult with their notified body as to the conformity assessment steps to be taken in case of a change in risk class. Meanwhile, devices can continue to be marketed under their current risk class, provided they meet all necessary requirements for that risk class, such as batch testing according to Article 100(2)(b) of Regulation (EU) 2017/746.
The MDCG guidance on IVD classification (MDCG 2020-16) is being updated to reflect this 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.
Advice on SARS-CoV-2 on request from the Medical Device Coordination Group (29 January 2025)
Advice on SARS-CoV-2 on request from the Medical Device Coordination Group (29 January 2025)
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