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The EU’s implementation of the new In Vitro Medical Device Regulation (IVDR) “has ground to a halt in the wake of the COVID-19 outbreak,” MedTech Europe said, pressing the European Commission for help with the transition process for high-risk devices. Read More
The guidance explains how UV equipment should be used to decontaminate single-use devices and on soft surfaces, such as on personal protective equipment. Read More
Unless a specific exemption, approval or authority applies, devices must be entered in the ARTG before they can be sold in Australia, the agency said. Read More
The system will eventually be used to support surveillance of all medical devices and will enable patients to be contacted when safety concerns are identified. Read More
The FDA has received roughly 4,500 pre-Emergency Use Authorization (EUA) and EUA submissions, and the total volume of submissions received has doubled compared to a year ago. Read More
The United Kingdom will launch a new Medical Device Information System (MDIS) in January that aims to improve device monitoring and performance and link them to patient outcomes. Read More
Munich, Germany-based notified body TÜV SÜD has issued its first certificate for an in vitro medical device under the EU’s new In Vitro Medical Device Regulation (IVDR), marking the first IVDR certificate worldwide. Read More
Device manufacturers that have been denied a Certificate to Foreign Government (CFG) to export a product may file for a review of the decision, in a process laid out in a new FDA guidance issued Nov. 6. Read More