Despite frequent and rapid changes in the regulation process, companies cannot ignore the value of bringing medical devices to the Chinese market. It is a potential high-growth area for many global medical device manufacturers. So, if you’re a medical device...
The European Parliament has formally voted and adopted the amendment of its Medical Device Regulation (MDR) date of application. The Parliament has tabled and supported the four technical amendments proposed last week by the European Council, without additional...
Medical Device manufacturers are grappling with disruptions to their businesses as a result of the coronavirus pandemic. Many are experiencing adverse impact to their supply chain and operations, financial expectations and emergency response plans. The need for...
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 give us more time before we must submit information to the database including...
