Medical devices with measuring function are regularly used in healthcare systems all over the world with the aim of prevention, diagnosis, and treatment of diseases. Considering the importance of these devices in daily activities of medical professionals and impact of their measurements on the health of patients, safety and accuracy of their measurements is becoming the topic of interest.
Numerous international guidelines define how healthcare institutions should perform these conformity assessments but, in some countries, where those guidelines are not adopted, it is necessary to implement directives of new approach for various groups of medical devices. Directives of new approach in terms of medical devices and their conformity assessment can be implemented in the area of legal metrology, as it is done in Bosnia and Herzegovina.
Aim of these activities is to establish traceability of medical device measurements and to increase accuracy, precision, and reliability of medical measurements in order to increase quality of life.