Quote from VigiServe Admin on November 29, 2020, 7:19 AM

Undesirable occurrence from the medical device is every malfunction (loss of attribute values, absence or decrease of the effectiveness of medical devices in medical or technical sense or some other adverse reaction of medical devices), as well as every inaccuracy in labeling or instructions for use which could cause or has already caused death, serious deterioration of patients’, users’ or third persons’ health condition. Materiovigilance is a system of identifying, collecting, reporting and estimating undesirable occurrences and reacting to them, or safety corrective actions related to medical devices. Materiovigilance includes activities of collecting, estimating, understanding and reacting to new findings of risks arising from the use or application of medical devices, particularly of harmful effects on patients/users or health care professionals, interaction with other substances or products, contraindications, falsifications, reduced efficiency, malfunctions or technical defects. This area is regulated by the Regulation for monitoring adverse effects of medical devices in Bosnia and Herzegovina (materiovigilance) - “Official Gazette of Bosnia and Herzegovina”, no.58/12, 30 July 2012. This Regulation devises the system for identifying, collecting, informing and estimating adverse effects and responses to them, namely safety corrective actions related to medical devices and other responsibilities of participants in the system of materiovigilance.

 

The system of materiovigilance includes:

• manufacturers of medical devices authorized for the territory of Bosnia and Herzegovina;

• representatives of manufacturers of medical devices;

• legal entities responsible for wholesale and retail marketing of medical devices (importers, doctors, pharmacists, dentists and other medical workers/health professionals);

• the Agency for medicinal products and medical devices of B-H (hereinafter referred to as: the Agency), including the Committee for medical devices,

• conformity assessment bodies;

• users and others interested in the permanent safety of medical devices.

When adverse effects occur, criteria for their registration are the following:

• That there is suspicion of its connection to medical device;

• That adverse effect has caused or could cause patient’s death or deterioration of patient’s, user’s or any other person’s health conditions

If there is suspicion of adverse effect, participants of the system of materiovigilance are required to report the adverse effect to the Agency by mail, fax or e-mail. In circumstances when application or report are submitted verbally or electronically, it is always necessary to deliver it in written form as soon as possible.

The activities of the Agency in the procedure of materiovigilance are:

• filing users’ reports or those from other sources and forwarding the said reports to manufacturers without delay or translation, while assuring the confidentiality of the patient’s data

• monitoring investigation of adverse effect undertaken by a manufacturer, undertaking additional actions, if necessary, beside those carried out by manufacturer;

• depending on the result of the investigation, spreading of any information that can contribute to the future prevention of adverse effects (or to limit their consequences);

• encouragement for reporting of adverse events by users and other persons involved in distribution, delivery, releasing for use or marketing of a medical device, including organisations and individuals responsible for calibration insurance and for maintenance of the medical device

• assessment of reports along with consultation with manufacturer or its representative, if possible; advising, if necessary, and intervention, when it is necessary;

The deadlines for reporting of the adverse reactions related to medical devices are:

• for serious threat to public health: IMMEDIATELY, no later than two days after the manufacturer has become aware of the threat

• for patient’s death or unexpected serious deterioration of patient’s health condition: IMMEDIATELY, no later than ten days after the manufacturer of the medical device has detected connection between medical device and adverse event;

• for other adverse reactions: IMMEDIATELY, no later than thirty days after manufacturer of the medical device has established connection between medical device and adverse event

In case that a report of adverse reaction has been filed to the Agency by a user or a health care professional, the report should be forwarded to the manufacturer which is required to verify the report according to the criteria of registering and to reply to the Agency with a report of adverse event or with an explanation why it is not necessary to register that event.