BVMed: More-Burdensome Regulatory Process Would Not Improve Medical Device Safety

German Medical Technology Association BVMed reports that just before the German parliamentary summer recess, a hearing on medical device safety was held by the Bundestag (German Parliament) Health Committee that involved official experts as well as experts from the medical device industry. The debate had been triggered by the Pip breast implant scandal. The Social Democratic and the Green Party submitted requests for regulatory approval of medical devices comparable to the approval procedures for pharmaceuticals while the Christian Democrats spoke in favor of a more differentiated discussion and a stronger regulatory component for high-risk products such as implants. The Federal Ministry of Health as well as the medical technology associations continue to support the proven CE-certification system.

BVMed Director General, Joachim M. Schmitt, stressed in his statement at the parliamentary Health Committee hearing that the approval of medical devices by state authorities would not contribute to increased safety but instead delay access to medical devices by patients. Furthermore, he said that the PIP scandal was not a problem of approval but rather of surveillance. “Therefore, we should do away with the lack of enforcement and introduce better controls and improved surveillance while adhering to the proven marketing approval regulations for medical devices,” said Schmitt.

For the entire press release, please go to the BVMed Website.

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Tags: Breast implant scandal, Bundestag, BVMed, German Parliament, medical device safety, PIP scandal