Trend towards higher standard of evidence for medical devices in Germany

Clinical trials are far less common in the medical device sector compared to pharmaceuticals. Little is known about the praxis of evidence generation for medical devices as there is currently no regulation in Europe that requires the registration of such studies or publication of their results. Therefore, the Institute for Quality and Efficiency in Health Care (IQWiG) has analyzed all applications for approval of clinical trials for medical devices submitted to the Berlin Ethics Commission between 2010 and 2013. In 2010, 63% of applications for treatment trials were randomized controlled trials (RCTs), and by 2013 this percentage had risen steadily to 86%.

IQWiG evaluated all applications submitted to the ethics committee between 2010 and 2013. The sample of 122 applications included 98 clinical trials for therapeutic interventions, 14 for diagnostic interventions and 10 for in vitro diagnostic medical devices. The majority of the 112 studies on medical devices accounted for the higher risk classes III and IIb (48 and 34). However, there were also studies on class IIa and class I products (18 and 12). About half of the studies explicitly aimed to prove not only the safety or performance, but also the effectiveness of the new medical device. Study applications were ultimately approved in all but four of the cases.

The share of RCTs on medical devices is significantly higher than expected. This trend might partly be caused by the enforcement of the Fourth Amendment to the Medical Devices Act 2010 which requires approval by an ethics committee and the higher federal authority (BfArM) for certain clinical trials on medical devices and in-vitro diagnostics. This is the case if the medical device either has no CE mark, is to be used outside its primary indication or if participants are exposed to more invasive measures.

Further speculates Sauerland, head of non-drug treatment at the IQWiG, that the trend is a response to increasing international legal regulation that will require higher standards of evidence from manufacturers of medical devices in the future.

The full report about clinical trials of medical devices is available in German here.

Subscribe to our newsletter delivered every second week not to miss important reimbursement information.