Medical Devices

On vigilance

The medical device vigilance system - purpose and activities

The principal purpose of a medical device vigilance system is to improve the protection of the health and safety of patients, users and other persons by various mechanisms of reducing the probability of recurrence of adverse incidents concerning medical devices. Medical device vigilance includes activities of gathering, assessing, understanding and reacting to new information on the risks resulting from the use or application of medical devices, especially of adverse incidents, interactions with other substances or devices, contraindications, counterfeiting, reduced or ineffective effects, malfunctions and technical defects.

Role of healthcare professionals in the medical device vigilance system

Although the Medical Devices Act (Official Gazette, no. 76/13) does not directly oblige users to report adverse incidents, their active participation is of vital importance. Users will be the first to notice an adverse incident and notify the manufacturer of the incident, and the implementation of corrective actions to reduce the risk and the probability of recurrence of the adverse incident relies on their close cooperation with the manufacturer.

Legal framework and significance

The Ordinance on Monitoring Adverse Incidents Related to Medical Devices (Official Gazette, no. 125/13) which defines in detail the legal framework of medical device vigilance draws on the European Commission’s Guidelines on a Medical Devices Vigilance System (MEDDEV 2.12). Since its accession to the European Union, Croatia has been an equal partner in the European system of monitoring adverse incidents which aims to increase transparency and strengthen the market surveillance of medical devices. As it improves the safety of medical devices, vigilance is in the interest of the user, as well as the manufacturer, providing them with feedback from practice to the risk management system.