
Clinical trials of medical devices
Clinical trials of medical devices in the Russian Federation are one of the important and complex stages of preparing a registration dossier for a medical device. In accordance with the legislation of the Russian Federation (Order of the Ministry of Health of the Russian Federation dated 30 August 2021 N 885n), clinical trials of MD for in vitro and non-in vitro diagnostics have different specifics and features. But despite the differences, the common feature is that clinical trials in all cases are conducted on the territory of the Russian Federation (manufacturers' trial results are not counted) and are conducted strictly in medical organizations that meet the requirements approved by the Ministry of Health of the Russian Federation.
Clinical trials always begin after the completion of biocompatibility and technical trials, which confirm the quality and safety of the medical device, because only after the successful completion of these trials can we begin to consider the issue of clinical effectiveness and safety for patients. It should also be noted that there are cases in which it may not be necessary to conduct biocompatibility or technical trials, but clinical trials are always required for the purpose of state registration of MD.
Clinical trials of medical devices (not in vitro) are conducted in two forms - in the form of clinical evaluation and with human subject. Clinical trials with human subject are complex and time-consuming. Let us discuss further how we can avoid such trials and conduct trials in the form of clinical evaluation.