Europe’s Medical Device Database – EUDAMED

Europe’s Medical Device Database – EUDAMED
January 26, 2022

Europe’s Medical Device Database – EUDAMED

ARTICLE BY: Marjeta Tušek Jelenc
CATEGORY: Regulatory Compliance

The European Commission adopted new Regulations in 2017 that apply to medical devices. There are two regulations, Medical Devices Regulation (MDR 2017/745) and the In Vitro Diagnostic Medical Devices Regulation (IVDR 2017/746). One of the goals of these regulations is to improve the transparency and coordination of data related to medical devices marketed in the EU. To accomplish this goal, the regulations call for a multipurpose database known as the European Database for Medical Devices (EUDAMED).

EUDAMED is the IT system used to monitor the safety and performance of both MDR and IVDR regulated medical devices. It will provide a living picture of the lifecycle of medical devices made available in the European Union (EU). It will integrate different electronic systems to collate and process information about medical devices and related companies (e.g., manufacturers) [1].

EUDAMED is structured around six interconnected modules: Actors registration, UDI/Devices registration, Notified Bodies and Certificates, Clinical Investigations and performance studies, Vigilance and post-market surveillance, and Market Surveillance.

Actually, EUDAMED has been in existence for many years but was only accessible by the European Commission and the National Competent Authorities. However, the new (updated) EUDAMED will be accessible by many more groups, such as Notified Bodies, Economic Operators (Authorised Representatives, Manufacturers, Importers), and the public. The inclusion of access to the public (via specific public sites) is one of the most significant benefits of the new EUDAMED.

For the first time in Europe, the public will be able to read up on medical devices so they will be able to make informed decisions before proceeding with procedures. Doctors and other medical professionals will also be better informed of any device-related issues, and the public will have access to the same data. EUDAMED aims to enhance overall transparency by improving the quality, safety, and reliability of medical devices by imposing stricter controls on high-risk devices, clinical evaluations, investigations, and the Notified Bodies that approve the certification of medical devices. EUDAMED also helps to enhance vigilance and market surveillance so that medical devices are still monitored even after they have been placed on the market [2].



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