Reassessment of SARS-CoV-2: Scientific Opinion of the Medical Devices Expert Panel

The MDCG scientific opinion on SARS-CoV-2 assesses the impact on the classification of IVD devices in accordance with Regulation (EU) 2017/746. The reassessment considers the evolution of the pandemic and the current epidemiological scenario, analysing transmissibility and life risk in the general population and in risk groups. This opinion is crucial for the medical device industry, especially to ensure regulatory compliance.