REGISTRY SNAPSHOT: European Database on Medical Devices (EUDAMED

by Staff writer,
Posted on 10/22/2019

European Union Electronic Register of Post-Authorization Studies (EU PAS Register) EUDAMED clinical trial transparency vendor services solution tech services consultant trialassure complianceKnowing where to submit clinical trial results summaries to is the easy part. What becomes difficult is learning the intricacies and transparency requirements of every clinical trial registry globally, including European Database on Medical Devices (EUDAMED). Here is an overview of this registry:

Registry name: European Database on Medical Devices (EUDAMED)

Year established: 2001

Points of interest:

  • EUDAMED is a database that allows users to exchange legal information about the implementation of the European Union (EU) Directives on medical devices between the European Commission’s Enterprise and Industry Directorate General and the competent authorities in EU member states
  • The main objective of the database is to help European authorities monitor the medical device market via information exchange
  • EUDAMED’s legal framework consists of the Medical Devices Directives 90/385/EEC, 93/42/EEC, and 98/79/EC
  • Users can upload, extract, and modify data on the registry
  • New regulations on medical devices call for a much wider EUDAMED database. Starting in the spring of 2020, the new rules will apply after a transitional period.
  • The new EUDAMED database will be publicly available in 2020.
  • New features on the EUDAMED database will include systems for registration, collaboration, notification, and dissemination.

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