The GKV-Spitzenverband has passed a new paper on the reform of medical device law. Here, it calls for high-risk medical devices to allow authorities to independently analyse whether they are clinically robust, and to monitor reliability.
The criticism of the GKV-Spitzenverband depends among other things on the fact that in high-risk products of class III, clinical studies are not always required to be carried out. Moreover, there is no reporting requirements. For this reason, it welcomes the idea of funds building an independent, central regulatory institution at a European level. This institute will, in the future, regulate high-risk products, undertake clinical trials and define their standards.
The background of the position paper is that the funds will represent a single position to the European Union. The European Commission wants to renew the medical device law after the scandal over faulty breast implants.
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