In a statement released on the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband, GKV-SV) website on the 26 November 2018, the CEO of the GKV-SV, Doris Pfeiffer, claimed there are not enough regulations to ensure safety for patients requiring medical devices, stating:
“With medical devices, dummy innovations and even harmful products are far too easy to supply. There are no safe rules and regulations that prevent this. For many years politicians have done too little here despite numerous reminders. The statutory health insurance has repeatedly pointed to these problems.”
She continues by highlighting how it is not a requirement for new products or methods used in hospitals to have their safety demonstrated by clinical trials and requests consistent implementation of the new European Medical Devices Regulations and compulsory scientific assessment of the benefits of the medical devices by the Federal Joint Committee, which would determine whether the device is paid for by the statutory health insurance. Consistent implementation of the new European Medical Devices Regulations would include making clinical trials an essential requirement.
Her final request is for the responsibility for medical devices to change from the industrial commissar to health commissioner, stating:
“The evaluation of medical devices must focus on patient benefit rather than industry interest. That is why we demand that in Brussels, the responsibility for medical devices should change from industrial commissar to health commissioner – first comes the patient’s well-being, then the industry interest. But unfortunately, it’s often the other way round.”