On 15th January health experts spoke at a hearing before the Health Committee of the Bundestag on the draft of the Medical Devices Adaptation Act. This law will come into force in May 2020 and is intended to align national regulations with those of the European Union and the Medical Device Regulation (MDR). The aim is to ensure greater patient safety throughout Europe through uniform medical device legislation. The most recent draft law provides, among other things, that in future restrictions or bans on unsafe and defective medical devices will no longer be the responsibility of the federal states, but of the higher federal authority, i.e. the Federal Institute for Drugs and Medical Devices and the Paul Ehrlich Institute. The umbrella organization of the statutory health insurance funds commented positively on this reorganization.
With regard to the reporting culture, the representatives of the Medical Service of the German National Association of Statutory Health Insurance Funds (MDS) called for an improvement in procedures to ensure patient safety. For example, the new legal system for the Adaptation Act is intended to promote the reporting of medical devices through binding feedback or sanctions. In this context, the health insurance companies demanded that, in the case of damaged products, the billing data of doctors and hospitals on products used in this way be recorded.
Criticism was also voiced by the health insurance companies and the MDS with regard to planned extensions of special approvals, as they are seeking to restrict special approvals in individual cases.
For small and medium-sized companies, the increased requirements could threaten their existence as a result of the Adaptation Act. According to estimates by the German Medical Technology Association (BVMed), it is possible that 10 to 15% of companies and their products will disappear from the market altogether.
On the other hand, the German Medical Association and the Working Group of Medical Ethics Committees welcome the fact that the new law strengthens the role of the ethics committees in clinical trials of products and at the same time makes it more transparent. The Medical Association and the Commission saw the only points of criticism in the short voting time of five days and the fact that the Ethics Commission was not involved in the amendment of the trial protocol.
With regard to the implementation of the adaptation law, extended testing procedures and unannounced inspections of manufacturers are planned, among other things. Likewise, high-risk products, such as implants, should be easier to trace in the future. On the whole, however, there has been criticism for some time now about the feasibility of the law. According to the MDR, for example, notified bodies such as the TÜV must undergo their own certification procedure and all medical products currently available on the market must be certified.
Furthermore, the European database for medical devices (Eudamed) is not expected to become operational until 2022. In the future, Eudamed will collect all data on products, such as manufacturers, certificates and test results.