EUDAMED – European Database on Medical Devices

Summary:

Compilation of information resources relating to the European Database on Medical Devices (EUDAMED).

Further information:

EUDAMED is a key aspect of the rules on medical devices and in vitro diagnostic medical devices introduced by Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR).

This database seeks to provide a living picture of the lifecycle of medical devices that are available in the European Union (EU). It integrates different electronic systems to collate and process information about medical device and related companies. It 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.

It is composed of six modules:

• Actor registration;
• Unique Device Identification (UDI) and device registration;
• Notified Bodies and certificates;
• Clinical investigations and performance studies;
• Vigilance and post-market surveillance;
• Market surveillance.

There is a gradual operationalisation of this database, spread across a number of years.

Official

European Commission: Official Website of the EUDAMED Database https://ec.europa.eu/tools/eudamed/#/screen/home

EUR-LEX: OJ L 426, 29/11/2021: Commission Implementing Regulation (EU) 2021/2078 laying down rules for the application of Regulation (EU) 2017/745 as regards the European Database on Medical Devices (Eudamed) https://eur-lex.europa.eu/eli/reg_impl/2021/2078/oj

EUR-LEX: OJ L 102, 23/04/2010: Commission Decision of 19 April 2010 on the European Databank on Medical Devices (Eudamed) http://data.europa.eu/eli/dec/2010/227/oj

European Commission: DG Health & Food Safety: EUDAMED https://webgate.ec.europa.eu/eudamed/landing-page#/

European Commission: DG Health & Food Safety: Medical Devices - EUDAMED https://health.ec.europa.eu/medical-devices-eudamed_en

European Commission: DG Health & Food Safety: EUDAMED Information Centre https://webgate.ec.europa.eu/eudamed-help/en/welcome-to-the-eudamed-information-centre.html

British Standards Institution: Insights: European Database on Medical Devices https://www.bsigroup.com/en-GB/insights-and-media/insights/brochures/european-database-on-medical-devices/

Slovenian Agency for Medicinal Products and Medical Devices (JASZMP): General information on medical devices: EudaMed European Database https://www.jazmp.si/en/medical-devices/general-information-on-medical-devices/eudamed-european-database/

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