On March 11, 2020, the World Health Organization designated “coronavirus disease 2019” (COVID-19) a global pandemic. As the number of cases worldwide continue to grow, social distancing has become the norm to slow the rate of transmission. The goal of course, is to...
Medical Device manufacturers are grappling with disruptions to their businesses as a result of the coronavirus pandemic, with many experiencing adverse impact to their supply chain and operations, their financial expectations and emergency response plans. The need...
Together we face a truly unprecedented situation being the global coronavirus pandemic (COVID-19) and its impact on our families, businesses, and our community way of life. As we continue to monitor the rapidly evolving situation around COVID-19, our first thought is...
The European Commission has announced a proposal to delay enforcement of the EU Medical Device Regulation by one year, from 26 May 2020 to 26 May 2021. The intent is to help relieve pressure from national competent authorities, notified bodies, industry and the...
The European Commission recently announced last November that the new EUDAMED will not launch until May 2022, even as the MDR takes effect in May 2020. While the delay in EUDAMED certainly helps give us more time before we must submit information to the database...
