EUDAMED - What is EUDAMED?

What is EUDAMED?

EU-DA-MED

European Database on Medical Devices

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The creation of a European database on medical devices (EUDAMED) is one of the key aspects of the new rules on medical devices (Regulation (EU) 2017/745) [MDR] and in vitro diagnostic medical devices (Regulation (EU) 2017/746) [IVDR].

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EUDAMED will provide a living picture of the lifecycle of medical devices that are 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). In doing so, EUDAMED aims to enhance overall transparency, including through better access to information for the public and healthcare professionals, and to enhance coordination between the different Member States in the EU.

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EUDAMED will be composed of six modules related to:

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• Actors registration
• UDI/Devices registration
• Notified Bodies and Certificates
• Clinical Investigations and performance studies
• Vigilance and post-market surveillance
• Market Surveillance

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What is the state of play of the implementation of EUDAMED?

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The use of EUDAMED is not yet mandatory nor required. Some modules are already available, and can be used voluntarily. However, their use cannot be imposed. In particular:

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• The module on Actor registration is available for voluntary use since December 2020
• The module on UDI/device registration is available for voluntary use since October 2021
• The module on Notified Bodies and Certificates is available for voluntary use since October 2021 except for the mechanism for scrutiny and the clinical evaluation consultation procedure (CECP) functionalities.
• The remaining modules, Vigilance, Clinical Investigation & Performance Studies and Market Surveillance, are under development and will be released when the entire EUDAMED system (including all six modules) is declared fully functional.

The mandatory use of the system will start when the entire EUDAMED system (including all 6 modules) has been declared fully functional following an independent audit and a Commission notice to be published in the Official Journal and in accordance with the transitional provisions set out in the medical devices regulations.

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Quite Recently, The European Commission published the timeline of when will this system be in place, functional and enforced for mandatory use.

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Read more about the EUDAMED Timeline by clicking here

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As the Regulatory Tools design and develop, Manufacturers need to focus on compliance with the requirements. Our Experts are here to cut through the regulatory maze and be your Regulatory Risk Partners for Medical Devices, Diagnostics and Digital Health!

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