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:

FIELD SAFETY CORRECTIVE ACTIONS

Field safety corrective action means corrective action taken by a manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident in relation to a device made available on the market.

The manufacturer or the Authorised representative of the manufacturer shall ensure that information about the field safety corrective action taken is brought without delay to the attention of users of the device in question by means of a field safety notice.

The manufacturer or his authorised representative must also notify the JAZMP of any safety corrective action to be implemented in the territory of the Republic of Slovenia.

 NOTIFICATION OF THE USERS

The manufacturer must ensure that users of the device concerned are informed without delay of the field safety corrective action taken.

The field safety corrective action shall be communicated to users in the form of a field safety notice.

Unless duly justified by the situation of the individual Member State, the content of the field safety notice shall be consistent in all Member States.

To inform users on the territory of the Republic of Slovenia, the field safety notice must be in Slovenian language.

Distributors and importers shall co-operate with the manufacturer and, where applicable, the manufacturer’s authorised representative, and the importer, and with competent authorities to ensure that the necessary corrective action to bring that device into conformity, to withdraw or to recall it, as appropriate, is taken.

TEMPLATES  for the field safety notice (most recent English version and older Slovenian version)

NOTIFICATION OF THE JAZMP

Using Slovenian or English form for reporting the Field Safety Corrective Action:

  • The manufacturer or his authorised representative must notify the JAZMP of any safety corrective action to be implemented in the territory of the Republic of Slovenia.
  • The manufacturer registered in the Republic of Slovenia, or its authorised representative registered in the Republic of Slovenia must notify the JAZMP of any field safety corrective measure taken, even if the medical device concerned is not on the Slovenian market or the field safety corrective measure does not concern the Slovenian market.

Please send the completed form, together with the associated Field Safety Notice, by email to meddev.vigilance@jazmp.si.

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