Case not yet closed on extra quality marks in Germany?
This article was originally published in Clinica
Executive Summary
The fate of additional quality marks in Germany over and above the CE marking may not be the foregone conclusion that it seemed only last month. The medical devices industry, in Germany in particular, has been urging that the CE marking be the single and only standard available, in order to avoid confusion in the market. Indeed, that is what is laid out in the proposed second amendment of the MPG, Germany's medical products law, which comes into effect next year (Clinica No 918, p 4).