The German med-tech associations Bvmed and VDGH have hit out at the shortcomings of the EU medical device regulations and are calling for action to improve implementation, predictability and transparency of the system.
The German Medical Technology Association, BVMed, and the French medical technology industries association, SNITEM, have issued a joint warning highlighting the risk of collapse in patient care throughout the EU.
With $41 billion in sales, the medical technology market in Germany leads Europe, followed by France and Italy, which each manage only half the sales of Germany each month. The U.K., in fourth place, barely sees one-fifth of Germany's revenues, according to a report from BVMed, the German association of medical device manufacturers. German firms also reported a 4.9% reduction in business in 2020 due principally to the COVID-19 pandemic.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA formally posts testing advisory after town hall discussion; HHS finalizes regulatory review rule; Lab in California hit for three months of false claims; BVMed calls for German med tech strategy.
