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German Industry Largely Positive On MDR Text, Fears Effects On SMEs

This article was originally published in Clinica

Executive Summary

The newly-issued English-language text of the EU Medical Device Regulation (MDR), as reported yesterday in Clinica, represents a good compromise that enhances patient safety in Europe. That was the initial reaction of German industry association BVMed, which adds that the Regulation will bring Europe-wide standards “up to the level of those in place in Germany”. The IVDR text was also published.