EU sets high bar for clinical data required for every CE marked product – By John Brosky, Contributing Writer  

BERLIN – The reform of rules governing the CE mark has shifted requirements for clinical evidence from nearly nothing to far more than most manufacturers can readily provide.  No product sold in the EU is spared as the law does not allow for the grandfathering of any of the estimated 500,000 products already on the market. Passed into law in May 2017, the rules fully apply in May 2020 after a transition period that will…

 

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http://medpass.org/wp-content/uploads/2017/11/BMT10262017.pdf