European Databank on Medical Devices – EUDAMED

As part of the implementation of the requirements of the EU Regulation 745/2017 on medical devices and the EU Regulation 746/2017 on in vitro diagnostic devices, the EUDAMED information system was extended (this is a significantly more widespread database compared to the current version of the database). An important change is that some information from the EUDAMED database will be available to both professionals and the general public. Thanks to several interconnected modules, EUDAMED will promote better transparency and information in the field of medical devices. EUDAMED will serve several purposes. It will function both as a registration system for the relevant economic operators and as a system for notification and dissemination of information.

The system will consist of several interconnected systems:

  • electronic system for registration of economic operators,
  • electronic system for registration of funds,
  • UDI database,
  • electronic system for notified bodies and certificates,
  • electronic system for clinical trials,
  • an electronic system for post-market vigilance and monitoring,
  • an electronic system for market surveillance.

At present, only the economic operator registration system is up and running. In May 2021, the launch of an electronic system for the registration of funds and the UDI database is planned. The full launch of all functionalities will take place in May 2022, together with the effectiveness of EU Regulation 746/2017 on in vitro diagnostic devices.

We will describe which economic entities are obliged to register in the EUDAMED system and how this process takes place in the next update.

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