Final texts of the EU MDR & IVDR (R = Regulation) have been released recently, the European Council is scheduled to hold a vote to adopt the legislation in March 2017, followed by a vote in the European Parliament in April. It is estimated that the transition periods will start sometime in the 2nd quarter of 2017. The MDD has a 3 year transition period and the IVDR has a 5 year transition period.

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