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 exponentially, social distancing has become the norm to slow the rate of transmission. The goal of...
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...
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...
European Commission announced last October that the new EUDAMED will not launch until May 2022, giving everyone enough time to properly prepare for implementing M2M data exchange with EUDAMED. Further, a grace period was also introduced by the EU for certain classes...
In September 2019, we witnessed PLM software giant, PTC Windchill, quietly exit the UDI compliance market. As we ended 2019, several little birds have shared that GHX is slated to phase out support for their GUDID Connector and will not be providing a EUDAMED...
