After years of European regulators pushing for a new legislation framework and weeks of speculation, the European Council (EC) seems to have made some progress and agreed to approach the new framework for medical devices and IVD (in vitro diagnostics) laws.
The original proposed guidelines started in 2012 with the goal of being adopted in 2014. However, the current discussions have carried over into 2015, and it but still does not look like it will pass until after the Latvian presidency ends this month. The EC is hoping adoption of these regulations will occur soon so they can promote increased reliability and safety to patients, as well as ensure that medical devices and IVDs are up to date with technological and scientific advances.
To find out more on the new framework legislation and the changes that will occur, continue reading here.
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