Post-marketing of medical devices means all types of activities for collection and analysis of the experience of using a medical device after its launch to the market in order to identify the necessary corrective and preventive measures for prevention or elimination of harmful effects.

In other words, this is systematic analysis of the experience of using a medical device after it was placed on the market.

The technical regulation on medical devices, as approved by Resolution of the Cabinet of Ministers of Ukraine No. 753 dated 02/10/2013, stipulates the obligation of the manufacturer to constantly update the clinical assessment and any related documentation with post-marketing surveillance data.

The new European regulation of medical devices (MDR 2017/745) significantly increases the role of post-marketing for medical devices and defines it as an ongoing process for updating clinical data on a medical device, which should be included in the manufacturer’s post-marketing surveillance plan.

For foreign manufacturers, post-marketing supervision in Ukraine is carried out by Authorized Representatives. That is why it is so important that the Authorized Representative possesses the necessary knowledge in the regulatory matters of distribution of medical devices and the understanding of post-marketing.

JERELO is ISO 13485 certified in the field of services of an Authorized Representative for manufacturers of medical devices. We have introduced and are supporting procedures for conducting post-marketing surveillance of medical devices in Ukraine. We know how the safety and efficacity of medical devices are monitored, what actions should be taken in the event of complaints, what is the procedure for notifying the competent authorities, and many other nuances of post-marketing.

For more information, please contact our specialists by phone _____________