QUOTED. April 25, 2018. Joerg Schickert.
The EU's new Medical Device Regulation doesn't appear to regulate 3D-printed medical products in the same way that all standard devices are controlled, Hogan Lovells attorney and life-sciences expert Joerg Schickert explains. See what he said about it here.
"The MDR does not specifically regulate 3D-printed medical devices nor the 3D printing manufacturing process. Since 3D printing is a relatively recent development, the MDR could have regulated this to some extent. But, in reality, we are struggling to understand the extent to which the regulations apply at all, and also, if they do apply, which part of the industrial process they apply to and to which materials." –Joerg Schickert, partner and life-sciences expert, Hogan Lovells
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