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23.4.2010ENOfficial Journal of the European Union 102/45DECISIONS COMMISSION DECISION of 19 April 2010 on the European Data bank on Medical Devices (Named) (notified under document C(2010) 2363) (Text
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Eudamed - eur-lex is needed by various stakeholders in the European Union (EU) who are involved in the field of medical devices. This includes manufacturers, authorized representatives, importers, distributors, clinical investigation sponsors, notified bodies, competent authorities, and actors involved in post-market surveillance activities.
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The purpose of Eudamed - eur-lex is to establish a centralized database for the exchange of information related to medical devices, clinical investigations, and other related activities in the EU. It facilitates the implementation and enforcement of EU regulations and directives concerning medical devices.
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Eudamed - eur-lex is a European database for medical devices where manufacturers and authorized representatives can report information about their products.
Manufacturers and authorized representatives of medical devices are required to file eudamed - eur-lex.
Eudamed - eur-lex can be filled out online through the official platform provided by the European Commission.
The purpose of eudamed - eur-lex is to provide a centralized system for the exchange of information related to medical devices in the European Union.
Information such as product details, clinical investigations, post-market surveillance data, and adverse events must be reported on eudamed - eur-lex.
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