The Rozy View: US Medtechs Face New Reg Burdens On Entering EU Market
The EU MDR and IVDR have finally been adopted, which is good news in the sense that regulatory certainty is guaranteed, but bad news in terms of the extra compliance costs that industry, including US medtechs, will have to face in the coming years.
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Following the recent vote in the European Parliament, the EU has finally adopted the Medical Device and IVD Regulations that were proposed back in September 2012. The texts, vastly longer and more complex than the three directives they are replacing, will establish a tougher regulatory code for the next decade or more, but where are the likely pressure points for industry and how can manufacturers prepare?
Late to the regulatory game India's government authorities may be, but device companies need to be on their toes to not lose out on vast future market opportunities as the "Make in India" program takes shape. That is the view of international device regulatory and market access expert Ed Rozynski. And while India is on the up, is Japan losing its attractiveness?
Recent days have seen a welter of industry association concern following the European Parliament’s ENVI committee’s vote on the