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29.08.2022.

According to the Medical Device Regulation (MDR) post-market surveillance is mandatory for all medical devices regardless of classification and it can be defined as an action necessary by medical device manufacturers for proactive collection and review of experience gained from the devices placed on the market with an aim of monitoring the performance of medical devices. PMS activities are designed in a way that they generate data regarding the deice performance and enable preventive identification of problems that can potentially arise during usage and subsequently cause problems in patient monitoring or treatment. Over the years, PMS has mostly relied on medical device manufacturers and users for reporting adverse events involving MDs to relevant authorities in addition to performing regular servicing activities. However, this approach is limited by manufacturer bias. Hence, an effective method of post-market surveillance has been developed based on the metrological characteristics of medical devices. According to this method, post-market surveillance consists of three steps: visual inspection, electrical safety inspection and performance inspection. 

Our Senior Research Associate, Prof. dr. Almir Badnjević will talk about this topic at the Fifth symposium of health technologies taking place on 29th of September. 


Prema Uredbi o medicinskim proizvodima (MDR) nadzor nakon stavljanja na tržište obvezan je za sve medicinske proizvode bez obzira na klasifikaciju i može se definisati kao radnja koju proizvođači medicinskih uređaja moraju proaktivno raditi i preispitivati ​​iskustva stečena sa medicinskim uređajima koji su na tražištu, s ciljem praćenja učinkovitosti medicinskih uređaj. PMS aktivnosti osmišljene su na način da generišu podatke o učinkovitosti i omogućuju preventivno prepoznavanje problema koji potencijalno mogu nastati tokom korištenja i posljedično uzrokovati probleme u praćenju ili liječenju pacijenata. Tijekom godina, PMS se uglavnom oslanjao na proizvođače medicinskih uređaja i korisnike za prijavu neželjenih ishoda koji uključuju liječnike nadležnim tijelima, uz obavljanje redovnih servisnih aktivnosti. Međutim, ovaj je pristup ograničen pristranošću proizvođača. Stoga je razvijena učinkovita metoda postmarketinškog nadzora koja se temelji na mjeriteljskim karakteristikama medicinskih proizvoda. Prema ovoj metodi, nadzor nakon stavljanja na tržište sastoji se od tri koraka: vizualni pregled, pregled električne sigurnosti i pregled performansi.

Naš Viši Naučni Saradnik, Prof. dr. Almir Badnjević će govoriti o ovoj temi na Petom sajmu zdravstvenih tehnologija koji se održava 29. septembra. 

 

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