Medical device makers face new obstacles to European approval

July 30, 2014 by Arezu Sarvestani

New materials regulations in the European Union mean medical devices have one more layer of red tape to cut through before they can reach the market.

Medical device makers looking to bring new products to the European market will find a new layer of regulation before they can attain CE Mark approval.

The European Commission’s new hazardous substances restrictions now apply to medical devices for the 1st time, requiring that all products coming to the E.U. market after July 22, 2014, meet materials standards before they get market approval.


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Josh Sandberg

Josh Sandberg is the President of Ortho Spine Partners and Partner for The De Angelis Group. He also serves as Co-Founder and Editor of OrthoSpineNews.

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