Surveillance of Medical Devices in Serbia

Surveillance of medical devices on the market

The obligation of medical devices surveillance on the market and the subsequent submission of reports is prescribed by the Medical Devices Act[1] (the “Law“) and the Rulebook on Surveillance of Medical Devices on the Market [2] (the “Rulebook“). The addressees to which the specific obligations refer are the manufacturers of the medical device and the authorized representatives of the foreign manufacturers of the medical device.

Obligations of surveillance and submission of reports are prescribed for the establishment of a system of early control and supervision of medical devices on the market, all for the prevention and protection of public health. With the mentioned system, the flows of medical devices on the market are not left only to spontaneous reactions to possible incidents (vigilance) of the medical device, but tries to control, monitor and direct these flows with a proactive approach.

The aim of the surveillance is to submit a report to the Medicines and Medical Devices Agency (the “MMDA“), which starting from 1st of June 2022 puts into operation its e-platform for submitting reports on the surveillance of each specific medical device.

Parallel medical device surveillance system

Post market surveillance, as it was said, is primarily the obligation of the manufacturer and the authorized representative of the foreign manufacturer. Surveillance of medical devices takes place also through market surveillance conducted by MMDA in cooperation with the Ministry of Health.

How is post market surveillance carried out?

Post market surveillance is only a part of a broader quality management system by the manufacturer of a medical device, which also applies to the authorized representative of a foreign manufacturer. To begin, it is necessary to adopt a plan for medical devices surveillance (the “Plan“), which will systematically link the following:

1) proactive and systematic procedure of collecting all information, which enables correct characterization of the performance of the medical device and comparison with similar medical devices available on the market;

2) efficient and appropriate methods and procedures for assessing the collected data;

3) appropriate indicators and thresholds used in the continuous reassessment of benefit-risk analysis, as well as risk management;

4) efficient and appropriate methods and tools for investigating complaints and analyzing market experiences gathered in the field;

5) methods and protocols for event management for which trend reports are submitted in accordance with the bylaws governing vigilance, including methods and protocols used to determine any statistically significant increase in the frequency or severity of adverse events, as well as the observation period;

6) methods and protocols for efficient communication with the ministry of health, MMDA, conformity assessment bodies, economic entities and users;

7) reference to the procedures for fulfilling the requirements prescribed by the bylaw regulating vigilance;

8) systemic procedures for identifying and initiating appropriate measures, including corrective measures;

9) effective tools for surveillance and identification of medical devices that may require corrective action;

10) a plan for post-marketing clinical surveillance of the medical device or an explanation of why post-marketing clinical surveillance is not applicable.

The information and data for collection provided by the Plan are:

1) information on incidents, including information from periodic safety reports (PSRs) and safety corrective measures in the field in accordance with the bylaws governing vigilance;

2) records related to non-serious adverse events and data on all adverse reactions in accordance with the bylaws governing vigilance;

3) information from the trend report in accordance with the bylaws governing the vigilance;

4) relevant specialist or technical literature, databases, ie registers;

5) information, including feedback and complaints submitted by users, distributors and importers, as well as persons responsible for the calibration and maintenance of the medical device;

6) publicly available information on similar medical devices;

7) information generated during the post-marketing clinical trial (interventional and non-interventional);

8) information obtained through the manufacturer’s quality control system, including lot verification testing for in vitro diagnostic medical devices before distribution, and after distribution evaluation of quality control system data and external quality assessment scheme (EQAS / QC).

Post-Marketing Surveillance Report (PMSR)

Manufacturers of medical devices and authorized representatives of foreign manufacturers, class I (except class Ir, Is and Im) and other in vitro diagnostic medical devices and in vitro diagnostic medical devices class A, compiles a Post Market Surveillance Report in which the results and conclusions of the analysis of post-marketing surveillance data collected are summarized as a result of the post-market surveillance plan, which contain an explanation and description of all preventive and corrective measures taken (if any). Manufacturers of medical devices and authorized representatives of foreign manufacturers will submit or update PMSR through the mentioned e-platform only at the request of MMDA, which does not release them from the obligation to make a Plan and to collect and process relevant data in accordance with the Law, Rulebook and Plan.

Periodic Safety Update Report (PSUR)

Manufacturers of medical devices and authorized representatives of foreign manufacturers, classes IIa, IIb and III, active implantable medical devices, in vitro diagnostic medical devices and medical devices for self-testing, compile a Periodic Safety Update Report 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-marketing surveillance data collected as a result of the post-marketing surveillance plan, which contains an explanation and description of all preventive and corrective measures taken.

During the lifetime of the medical device, the periodic safety update report shall state:

1) conclusions of determining the relationship between benefits and risks;

2) main findings of post-marketing clinical surveillance;

3) sales volume and assessment of the average size and other characteristics of the population that uses the medical device and the frequency of use where practical.

Manufacturers of medical devices and authorized representatives of foreign manufacturers will submit or update PSUR through the mentioned e-platform, as follows:

  • For medical resources IIa classes – at least once in two years;
  • For medical resources IIb and class III, active implantable medical funds and in vitro diagnostics medical devices and medical devices for self-testing – at least once a year;

In addition, for Class III medical device or implantable medical devices or in vitro diagnostic medical devices – List A, or in vitro diagnostic medical devices class D, in accordance with the bylaws governing the basic requirements for medical devices, the manufacturer shall submit the PSUR to the conformity assessment body involved in the conformity assessment. The evaluation of the conformity assessment body will be submitted to MMDA as an integral part of the PSUR.

Market Surveillance

Through market surveillance, MMDA conducts appropriate checks on the conformity of the characteristics and performance of medical devices, including, if necessary, review of documentation and physical or technical assessment of medical devices on the basis of adequate samples.

Market surveillance is conducted as:

  • Systematic control (in accordance with the annual plan carried out by MMDA, and in cooperation with the Ministry of Health);

 

  • Extraordinary control (in case of incidents, control is carried out by MMDA in cooperation with the Ministry of Health);

 

  • Regular inspection supervision (carried out by Inspection Department of the Ministry of Health for drugs, medical devices and psychoactive controlled substances and compliance precursors);

In conducting market surveillance, MMDA may request that the documentation and information necessary to conduct market surveillance activities be made available and, where justified, the provision of necessary samples or access to a medical device, as well as the results of the authorized body’s technical assessment.

If MMDA determine that the medical device poses an unacceptable risk to public health or the safety of patients, users or other persons or other aspects of public health, it will propose to the Ministry of Health to take all appropriate and justified preventive and/or corrective measures, to prohibit or restrict the placing of a medical device on the market, to make the placing of a medical device on the market conditional on specific requirements, to order urgent withdrawal or withdrawal of a medical device within a reasonable time, proportional to the nature of risk. The manufacturer of the medical device, or other relevant entity shall take all appropriate and justified preventive or corrective measures in order to harmonize the medical device with the requirements prescribed by the Law and bylaws adopted for its implementation, which relate to that risk. These measures shall be taken in a manner proportionate to the nature of the risk.

In the case of a medical device for which a certificate of conformity has been issued, MMDA and the Ministry of Health shall inform the conformity assessment body that issued the certificate about the results of the assessment and the imposed measures without delay.

If, after conducting the assessment, MMDA determines that the medical device does not comply with the requirements prescribed by law and bylaws, but does not pose an unacceptable risk to public health or safety of patients, users or other persons or other aspects of public health, shall instruct the relevant entity to eliminate the non-compliance within a reasonable, clearly defined period that is proportionate to the non-compliance. If the entity does not eliminate the non-compliance within the given deadline, MMDA immediately proposes to the Ministry of Health to take all appropriate measures to restrict or prohibit the placing on the market or ensure its return or withdrawal from the market, also notifying the conformity assessment body that issued the certificate.

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[1] Medical Act _ funds (“Official Gazette of RS”, No. 105/2017)

[2] Rulebook on surveillance medical devices on the market (“Official Gazette of RS”, No. 102/2018 and 58/2021)