Medical scandal: Increased safety of medical devices
The Federal Council has approved the dispatch on the amendment of the Therapeutic Products Act and Human Research Act for the attention of parliament. The draft law is intended to improve the safety and quality of medical devices and thus patient safety in Switzerland.
Several incidents and scandals involving medical devices such as leaking Silicone-In Europe, doubts about the system for controlling medical devices arose due to the failure of breast implants and defective hip prostheses. As a result, the EU modernized its legal framework in May 2017 and made it significantly stricter in two new EU regulations.
Switzerland currently has equivalent regulation for medical devices as the EU. The Switzerland-EU agreement on mutual recognition of conformity assessments allows Switzerland to participate in European market surveillance. By adapting Swiss medical device legislation to the stricter EU regulations, the safety and quality of medical devices should also be improved in Switzerland.
This requires adjustments in the Therapeutic Products Act (HMG) and in the Human Research Act (HFG) are necessary. The requirements will be tightened for all players involved. In the case of high-risk products, for example, manufacturers must substantiate the benefits and usefulness of the products with clinical data and assess their safety. The criteria for approval and monitoring of clinical trials and performance testing will be made stricter. At the same time, the requirements and responsibilities for the competent authorities as well as for the privately organized conformity assessment bodies will be made much stricter. Market surveillance by Swissmedic will be strengthened. Furthermore, the clear identification of all products is to enable their complete traceability. In addition, relevant data will be made available to the public in a comprehensible form within the framework of a central European database for medical devices.
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