The European Commission’s Medical Device Coordination Group (MDCG) posted five new guidances on Friday (4/24) for medical devices in light of COVID-19. These guidances are used when demonstrating equivalence to existing devices, generating sufficient clinical evidence for relevant general safety and performance requirements (GSPR) for legacy devices, providing post-market clinical follow-up and evaluation templates, and guidances on entrance of ventilators into the market as quickly and safely as possible.
Read more here: https://www.raps.org/news-and-articles/news-articles/2020/4/mdcg-posts-five-new-guidances
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