Update of legislation in the field of safety monitoring of medical devices (Analysis of Order 1113n).
In the previous article devoted to the update regarding safety monitoring, we considered Order 980n “On Approval of the Procedure for Safety Monitoring of Medical Devices” . In this small review, we would like to refer to Order 1113n, which will replace the Order 12n on January 1, 2021 and will be valid until January 1, 2027.
Before talking about the difference between the two above-mentioned Orders, we would like to indicate what will be discussed. Both Orders (12n & 1113n) have the same name and cover regulatory issues of, roughly speaking, unexpected, undescribed events, namely, […] all cases of detecting adverse events not specified in the instructions for use or the MD manual, on undesirable reactions in its application, about the peculiarities of interaction of medical devices among themselves, the facts and the circumstanes that create threat to the life and health of citizens and health workers in the use and operation of medical devices.
Previously, according to Order 12n, all participants of the MD circulation were obliged to report on the events within 20 working days. Further actions were not regulated by the Order.
With the entry into force of Order 1113n, all participants of the circulation will still have to report on the Events within 20 working days. However, further the manufacturer/AR will have to perform several additional actions:
- Prepare a report on an adverse event for the RZN in accordance with Appendix 2 to the Order:
|Adverse event criterion||Deadline for reporting|
|Serious health threat||No later than 2 calendar days*|
|Death/ unforeseen serious deterioration of the user’s health||No later than 10 calendar days*|
|Other cases||No later than 30 calendar days*|
*from the moment it became known
- Prepare a report on corrective actions according to Appendix 3 to the Order
- Issue a safety notice in accordance with Appendix 4 to the Order on the results of corrective actions
Interestingly, there are cases where reports of adverse events may not be provided in the RZN. This, for example, refers to adverse events that are already described in safety notices and occurred after adverse events were investigated and corrective actions were carried out. Also reporting of each individual event can be avoided if each of these, often occurring, is documented (indicated in risk analysis/reports on them were analyzed by manufacturer/AR + RZN).
However, for these events, there is a caveat that, yes, a report may not be provided for each event, but in this case, it is permissible to submit periodic consolidated reports, the content and timing of which should be agreed with the RZN.
Such wording certainly entails some questions: At what time is agreement necessary? How is it carried out? Etc.
In addition, the Order pays special attention to medical devices of risk classes 3 and 2b (implantable). According to the new requirements, manufacturers of MD/AR are obliged to monitor safety and clinical efficacy after registration of such MD for 3 years and provide reports on clinical monitoring in RZN in accordance with Appendix 5 to the Order.
Reports on clinical monitoring are submitted to the RZN not later than February 1, starting from the year following the year of receipt of the registration certificate.
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