Medical device vigilance

INCIDENTS INVOLVING MEDICAL DEVICES

With an increasing number of medical devices in use or on the market, complications can arise that may be serious or pose a public health threat. Complications related to medical devices are recorded in the medical device vigilance system provided for by the Medical Device Regulation (EU) 2017/745.

The medical device vigilance system has been set up to protect public health and the health and safety of patients and other users of medical devices through the introduction of field safety corrective actions and the reduction of the possibility of recurrence of a medical device-related incident that has been noted in the past.

Activities performed by the JAZMP in relation to the vigilance system include collecting and evaluating serious incident reports in cooperation with the manufacturer of medical devices or its representative, monitoring the manufacturer or its representative in investigating the incident, implementing any further measures necessary to complement the measures taken by the manufacturer or its representative, and participating in the international medical device vigilance system.

‘Incident‘ means any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use error due to ergonomic characteristics, as well as any inadequacy in the information provided by the manufacturer and any undesirable side effect, and ‘serious incident’ means any incident that directly or indirectly leads to or might lead to:
  1. the death of the patient, user or other person;
  2. the temporary or permanent serious deterioration in the state of health of the patient, user or other person;
  3. a serious public health threat.

‘Serious public health threat‘ means an incident that could result in an imminent risk of death, a serious deterioration in a person’s state of health, or a serious illness, which may require prompt remedial action, and that may cause significant morbidity or mortality in humans, or that is unusual or unexpected for the given place and time;

Participants in the medical device vigilance system must report any serious incident involving medical devices that occurs in the territory of the Republic of Slovenia to the JAZMP.

For urgent vigilance reports, the JAZMP can be reached by:

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