Аnalysis of the opportunities provided by the new eudamed medical device information system

Аnalysis of the opportunities provided by the new eudamed medical device information system

Poster

Paola Petkova1, Evgeni Grigorov2, Petko Salchev3,4
1PhD candidate, National Center for Public health and analyzes, Sofia
2Faculty of Pharmacy, Medical University-Varna
3Governor at National Health Insurance Fund
4National Center for Public health and analyzes, Sofia

Introduction: The EUDAMED system is an information technology system that is used to manage the activities of the medical devices industry. It is part of the implementation of two regulations (Regulation (EU) 2017/745 and Regulation (EU) 2017/746) related to the use of medical devices. Aim: To analyse the main opportunities and information provided by the new EUDAMED medical device information system. Аs well as тo anticipate the benefits of using the system. Materials and methods: The study contains analysis of the information available on the public website EUDAMED and a review of the main functions of the system. Results: The platform is a collaborative and interoperable and will serve as a registration, collaboration, and dissemination system. Actors registration, UDI/Devices registration, Notified Bodies and Certificates, Clinical Investigations and performance studies, Vigilance and post-market surveillance, and Market Surveillance are the six interrelated modules that make up EUDAMED. Eudamed contains in example the registration of manufacturers, declaration of conformity, ISO certificate, proof of QMS, labeling and instructions and etc. Conclusion: The system is not yet mandatory, as all six modules are not active. The forecast is that by the middle of 2023 all modules will be ready and in 2026 the system will become mandatory for use. EUDAMED ensure transparency and strengthen safety requirements. The system will be accessible to Competent Authorities, the Medical Devices Coordination Group (MDCG), Notified Bodies (NBs), Economic Operators (manufacturers, authorized representatives, importers, sponsors), as well the public and healthcare providers.
Keywords: medical devices, EUDAMED, information