by Innovit Corporate Affairs | Sep 8, 2020 | Blog, Eudamed, GUDID
The European Database for Medical Devices (EUDAMED) EU MDR, the European Union’s Medical Device Regulation is intended to support both pre-market product registration processes and post-market surveillance & vigilance activities by national regulators across the...
by Innovit Corporate Affairs | Apr 22, 2020 | Blog, MDR
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...
by Innovit Corporate Affairs | Mar 30, 2020 | Blog
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...
by Innovit Corporate Affairs | Mar 25, 2020 | Blog, MDR
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...
by Innovit Corporate Affairs | Mar 10, 2020 | Blog, Eudamed
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...
