From January 1, 2021, a new procedure for reporting adverse events when using medical devices will come into force
The Ministry of Health has defined the rules for presenting information about the adverse effects and complications that have arisen when using MI. We are talking about the identified side effects that are not indicated in the instructions for use, about adverse reactions during the operation of medical devices, the peculiarities of the interaction between medical devices, facts and circumstances that pose a threat to the life and health of citizens and health workers.
It is required to transmit information to Roszdravnadzor within 20 working days from the date of detection of adverse events. A recommended sample for reporting such events has been approved. Copies of supporting documents must be attached to it and the type of adverse event must be indicated. A directory of the types of such events is posted on the agency’s website.
The medical device manufacturer will have to send a report on the adverse event and a report on corrective actions for the safety of medical devices to Roszdravnadzor.
A timeline has been set for sending the initial adverse event report.
There is also a list of cases where adverse event reporting is not required (for example, when the adverse event is due to a defect in the medical device that can be detected during use).
Under the new procedure, medical organizations must inform the manufacturer of medical devices (their AMR) about adverse events and provide him with access to such medical devices.
It is stipulated that an authorized official is responsible for the transmission of data on adverse events that have occurred in the organization. It is obliged to collect and send information to Roszdravnadzor, monitor information letters on the agency’s website and carry out the activities specified in them. The order of activities and responsibilities of the responsible person are approved by the local regulations of the organization.
For failure to provide information about adverse events when using MI, the offender may be held liable under Art. 19.7.8 Administrative Code of the Russian Federation.