Surveillance of medical devices in the market includes post market surveillance and market surveillance.
The regulations in the field of “surveillance” of medical devices relies on the EU regulation, that is, on European directives (98/79 EC, 93/42 EEC, 98/385 EEC) or on new EU regulations (“(EU) 2017/745”/ “(EU) 2017/746”).
Post market surveillance means all activities carried out by the manufacturer, i.e. the manufacturer’s authorized representative, which establishes and maintains a systematic procedure for proactive collection and evaluation of experiences related to the medical device that has been marketed or used. , for the purpose of identifying any need to apply all necessary corrective and preventive measures without delay.
Market surveillance means the activities carried out and the measures taken by the Ministry and the Medicines and Medical Devices Agency of Serbia in order to check and ensure that medical devices comply with the basic requirements, as well as that they do not endanger health, safety or any another aspect of protecting the general interest.
The manufacturer, or the manufacturer’s authorized representative, is obliged to continuously monitor the medical device on the market in order to identify any need to immediately apply all necessary corrective or preventive measures. The manufacturer, i.e. the manufacturer’s authorized representative, keeps records of implemented corrective and preventive measures and is obliged to report the Agency thereof.
The Agency provides, organizes, and coordinates the collection and analysis of data obtained after a medical device has been marketed. The Agency may require the manufacturer, or the manufacturer’s authorized representative, to submit a reasoned and evidence-based report on the experiences related to the marketed medical device.
In connection with the market surveillance of the medical device, two types of reports are submitted to the Agency:
1. Post-Market Surveillance Report (PMSR)- The manufacturer of class I medical device (except Is, Im, Ir) and class Other In vitro diagnostic medical devices (Other IVD), i.e. in vitro diagnostic medical devices of class A, compiles a Post-Market Surveillance Report (PMSR) in which it summarizes the results and conclusions of the analysis of the post-market surveillance data collected as a result of the post-market surveillance plan, which contains an explanation and description of all taken preventive and corrective measures. The report is updated as necessary and is submitted to the Agency upon request.
2. Periodic Safety Update Report (PSUR)
The Manufacturer of Class Is, Im, Ir, Iia, Iib, III Medical Device, Active Implantable Medical Devices (AIMD), In Vitro Diagnostic Medical Devices Class: List A, List B, Self-Test and In Vitro Diagnostic Medical Devices of Class B, Class C and class D shall draw up a Periodic Safety Update Report (PSUR) for each medical device and, if relevant, for each category or group of medical devices, in which it summarizes the results and conclusions of the analysis of post-market surveillance data collected as a result of the post-market surveillance plan, containing an explanation and description of all taken preventive and corrective measures taken.