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    EU MDR: Learning as We Go

    With full application of the EU Medical Device Regulation (EU MDR) just around the corner on 26 May 2020, it’s fair to say many device manufacturers and regulatory professionals are on edge. And although we are coming to the end of the three-year transition period, it’s sometimes seemed like we have been struggling to play catch up from very start of the process.   Some of that is in the nature and scale of EU MDR as compared to the Medical Device Directive that has be...
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    6 Things You Need to Do to Prepare for the New EU Medical Devices Regulation

    When the EU’s new Medical Devices Regulation ( MDR ) entered into force last month, it set in motion a three-year countdown to the new rules’ full application in 2020. For companies marketing devices in the EU that wish to continue to do so, there is a lot to do in that relatively short time, so it is critical to begin as soon as possible. Early preparation is key. Following are six things you should be doing to get ready. 1. Plan Ahead In order to figure out wh...