Post Market surveillance (PMS) for medical devices and IVD in EAEU-bg

Post Market surveillance (PMS) for medical devices and IVD in EAEU

The rules for monitoring the safety, quality and effectiveness of medical devices are established by the Decision of the EAEU Board of December 22, 2015 № 174

Monitoring is based on:

a) analysis of reports of adverse events (incidents) at all stages of circulation of medical devices (MD), received by:

from MD users;

from MD manufacturers;

when the authorized bodies of the member states of the Union exercise state control (vigilance) over the circulation of medical devices;

b) analysis of periodic reports on the safety and clinical effectiveness of MD (MD class 3, implantable MD class 2b) (post-registration clinical monitoring)

c) system for collecting and analyzing data from the medical device manufacturer on the safety and effectiveness of medical devices at the post-sale stage and taking corrective actions

The manufacturer of the medical device or its authorized representative is obliged to submit to the authorized body of the Union member state in whose territory the adverse event (incident) occurred a report on the adverse event (incident) and a report on corrective actions on the safety of the medical device.

The rules for the adoption by authorized bodies of the EAEU member states of measures to suspend or prohibit the use of medical devices that pose a danger to the life and (or) health of people, poor quality, counterfeit or falsified medical devices, as well as their withdrawal from circulation in the territories of the member states are established by the Decision of the EEC Council dated 12.21.2016 № 141. 

If inconsistencies (dangers of use) are identified, the authorized body may suspend the use of medical devices for a period of up to 180 days, with the possibility of extension. Also, the suspension of the use of medical devices can occur on the basis of a statement from the manufacturer (with justification for the reasons for the suspension of use).

After eliminating the circumstances that led to the suspension of the use of medical device, the authorized body resumes the use of medical device. If the circumstances have not been eliminated, the authorized body makes a decision to prohibit the use of the medical device and withdraw it from circulation.

If a counterfeit or falsified medical device is detected in circulation on the territory of its state, the authorized body carries out verification activities and makes a decision to prohibit the use and withdraw from circulation on the territory of a member state of the counterfeit or falsified medical device. Post-registration clinical monitoring of the safety and effectiveness of medical devices consists of annual submission of clinical monitoring reports to the authorized body of the reference state for 3 years. Post-registration clinical monitoring is carried out in accordance with the plan included in the report on clinical evidence of the effectiveness and safety of medical devices, submitted by the medical device manufacturer or its authorized representative as part of the registration dossier. If the manufacturer does not provide reports, the authorized body has the right to suspend the registration certificate of the medical device or decide to initiate a procedure for its cancellation.

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