Advice on SARS-CoV-2 on request from the Medical Device Coordination Group (29 January 2025)

At the request of EU MDCG, EMA Expert Scientific Committee was asked to provide a scientific opinion on the current status of SAR-CoV-19, so they can review the current classification as an EU Class D device. Please find below link to the Scientific opinion and the update on the MDCG webpage. Future updates of the MDCG Guidance on classification will…