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Spotlight on the EU Medical Device Regulations
On Sept. 26, the European Commission released proposed legislation revising the EU’s medical device and in vitro diagnostic device directives and setting the stage for the revisions to be implemented uniformly across member states as regulations. The proposed regulations include a number of provisions aimed at strengthening premarket and postmarket controls of medtech products authorized in EU markets. In the coming months, IMDRM will focus on some of the more significant reforms to prepare devicemakers for the changes to come.
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