The recent document from the European Commission's Medical Devices Coordination Group concerning device registration timelines is difficult to follow, with its many unexplained references. This article aims to clarify how the MDCG's findings affect the way manufacturers should prepare for MDR compliance.
Device and diagnostics manufacturers doing business in the EU market will have to register in the Eudamed medical device database a comprehensive series of device data elements within 18 months of the full application of the Regulations (the MDR on May 26, 2020, and the IVDR on May 26, 2022).
But if there is a delay leading to the database not being ready by March 25, 2020 (the date scheduled...
Healthcare product industries await publication of the NHS 10-Year Plan, due out the coming days, which will focus on health generally not just the NHS, UK health secretary Wes Streeting said during a final prelaunch event on 24 June.
From June 30, new European Commission rules will attempt to redress an imbalance in medtech trade between the EU and the People’s Republic of China.
Legal experts warn, however, that new Mexican procurement rules are discriminatory and could be challenged in the courts.
