EUDAMED is a digital system belonging to the European Union that serves as a digital registry containing information on all medical devices and in vitro devices that exist on the EU market. The European Commission created EUDAMED as part of the MDR and IVDR regulations in Europe that govern the steps manufacturers need to take to develop safe and effective medical devices and in vitro devices. The IT system comprises six interconnected modules: actors registration, UDIs/Devices registration, notified bodies and certificates, clinical investigations and performance studies, vigilance and post-market surveillance and market surveillance.

How does structured content help?

With the help of structured content, medical device manufacturers can create XML content. XML content represents one of the ways manufacturers can submit content to EUDAMED. While organizations can manually enter information through EUDAMED’s user interface, XML file uploads and machine-to-machine data exchange are two methods medical device organizations can use to save time and resources while submitting accurate, consistent and up-to-date information in the EUDAMED system.

Key benefits

  • Reduce costs for creating medical device technical documentation
  • Ensure consistent and accurate information throughout all stages of medical device development
  • Speed-up regulatory submissions
  • Create better communication streams with notified bodies and other regulatory bodies