A Novel Method for Monitoring Notified Bodies Designated under The European Union Medical Device Regulation

Authors : Tuncay Bayrak

Pages : 415-421

Doi:10.19113/sdufenbed.1508221

View : 22 | Download : 28

Publication Date : 2024-12-23

Article Type : Research Paper

Abstract :Notified bodies, which perform conformity assessments, play a crucial role in protecting patient health and providing access to safety products on the market. The EU 2017/745 Medical Device Regulation (MDR) brings stricter rules and responsibilities for notified bodies. Designating authorities (DAs), who are also responsible for monitoring notified bodies, have not been provided with any guidance documents or written procedures. In this study, for the first time, we proposed a methodology aided by a digital system to monitor notified bodies effectively. We conducted a need analysis based on the MDR requirements and the relevant guidance documents, and we introduced a six-component technique for monitoring of the medical device notified bodies. Then, we identified the subcriteria of each component and created business activity diagrams for the main processes to monitor the notified bodies. There are now forty-eight notified bodies available under the MDR. Our monitoring approach consists of six steps that cover all NB-related activities, such as review of technical documentation assessment, personnel authorization, and surveillance of the certified product on the market. The proposed system complies with the MDR requirements and handles all critical performance indicators of NBs. The new MDR requirements for NBs also require an advanced monitoring system for DAs. This study focused on the critical points for monitoring NBs. Member states should implement the proposed methodology and the activity diagrams to have an efficient monitoring system in accordance with MDR requirements. A similar system can be used for monitoring of the other conformity assessment bodies.
Keywords : İzleme, dijitalleşme, tıbbi cihaz, uygunluk değerlendirmesi, mevzuat, onaylanmış kuruluş