Update of legislation in the field of safety monitoring of medical devices (Analysis of Order 980n).
With the new year 2021, all subjects of circulation of medical devices, especially the manufacturer and its authorized representative (AR), expect innovations related to safety monitoring of medical devices. From January 1, 2021, two legislative acts (Order No. 980n from 15th Sept 2020 (monitoring system) and Order No. 1113n) come into force, which significantly details the procedure for interaction between participants of the market of MD and Roszdravnadzor (RZN). The orders will be in force until January 01, 2027.
Thus, Order 980n from 15th Sept 2020 (monitoring system) determines who, what and in what time should do in case of receipt by RZN the information:
- On adverse events received from the subjects of MD circulation;
- Received during the implementation of state circulation medical device control;
- Posted on official websites of foreign regulatory bodies in the field of MD circulation, about adverse events that occurred in other states, with the MD registered in Russia;
- On safety and clinical efficacy in the use of MD of risk classes 3 and 2b (implantable MI) obtained from manufacturers of MD/their ARs;
- On adverse events on implanted MD obtained from specialized registers and information systems;
- Provided by the MD manufacturer about an adverse event […] that resulted in the death or serious deterioration of the user’s health.
Upon receipt of this, the following process is initiated:
|RZN||Registers received information in the automated information system (AIS)||On the day of info receipt|
|RZN||Notifies the manufacturer of MD/AR about the need to provide a motivated opinion on the event||5 working days*|
|Manufacturer/AR||Prepares a motivated opinionincluding (if necessary) reports on adverse events and corrective actions||10 working days*|
|RZN||Directs the received information to the expert institution (FGBU)||Not appointed|
|FGBU||Directs to the RZN an expert opinion on the causal relationship between the use of MD and the development of detected adverse events and the presence in the IFU of the risk of development detected adverse events||3 working days*|
|FGBU||Provides an expert opinion to the RZN with recommendations on the need or absence of need for control and supervisory measures and regulatory decisions in relation to medical device.**||10 working days*|
|RZN||Decides to conduct control measures||10 working days***|
|Manufacturer/AR||Develops and directs to the RZN a program of measures to prevent damage to life and health of citizens and medical workers in the use of MD, if in the course of control actions confirmed the facts of damage to
life and health of citizens in the application of MD
|10 working days*|
|RZN||Directs the Program to an expert institution||10 working days*|
|FGBU||Prepares Conclusion on sufficiency of proposed measures||15 working days|
|RZN||Notifies the Manufacturer/AR about the acceptance of the program or the need for changes to the Programme, indicating such changes||10 working days|
|Manufacturer/AR||Makes changes to the Program**||10 working days|
*from the date of receipt of information
***from the date of receipt of the last document (motivated opinion + expert opinion+ expert opinion)
Manufacturer/AR is obliged to provide buyers, including consumers, with the opportunity to obtain operational information on measures to prevent damage to life and health of citizens and medical workers in the use of MD.
Thus, Order 980n prescribes the entire chain of events occurring from the moment of receipt of information about an adverse event to the development of a corrective action strategy.
However, some technical details of the process are not clearly described.
For example, in what time does the RZN provide a motivated opinion of the manufacturer/AR to an expert institution?
What are the requirements to the manufacturer’s/AR’s motivated opinion & Programe formation?
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