GERMANY Trends and Developments Contributed by: Ulrich Grau, Constanze Püschel and Tobias Volkwein, D+B Lawyers
Regulation (the “MDR” ), which sets the regu- latory framework for the marketability of their products. This demands an understanding of the new legal requirements and the implications for the certification process and the design of quality management systems. The industry in Germany was also relieved by the news that, after months of discussions, the tran- sitional provisions of the MDR were extended. However, even with more time, the preparation for stricter regulations remains challenging for the industry, with many questions still unan- swered. Correspondingly, new proposals for fur- ther facilitations in practical terms have already been submitted.
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