EUDAMED Reed Tech Insights Series

This series is designed to provide a ‘deep-dive’ into understanding and preparing medical device product data for EU UDI submission. Learn more about the data attributes, regulatory, legislation, and distinct differences between FDA GUDID and EU EUDAMED.

What is EU UDI (EUDAMED)

EUDAMED  (European Database on Medical Devices) is the web-based portal implemented by the European Commission to serve as a centralized database for economic operators (medical device manufacturers world-wide, designated representatives and system/procedure pack providers) for the registration and required EU regulatory information submission. This industry activity is a key component of the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), replacing the former EU directives in these categories, dictated by specific timing scenarios. Unique Device Identification (UDI) database requirements are being implemented by global health regulators to improve the safety of patients and facilitate product modernization.

The European Union system for UDI-DI (EUDAMED) has some similarities to the US FDA. A main differentiator to the data tree is a ‘basic unique device identification’ level of data or BUDI-DI. The BUDI-DI data attribute categorizes medical devices that use the same identifier in the same group. BUDI is the main identifier of a model, while the DI is the specific device unit.

EU UDI (EUDAMED) preparations are ongoing with some anticipated milestones. Note that as conditions change, continuing guidelines are expected from the European Union.

  • 2020 December: The EUDAMED Actor module is a voluntary production deployment. Economic operators can interface with EUDAMED and acquire the needed registration SRN (Single Registration Number) for certificates.
  • 2021 May 26: MDR DoA (Date of Application)
  • Expected By 2021 September:  EUDAMED Device/UDI Registration, Certificates and Notified Bodies modules (after the Actor module, as soon as functional). At this time, it is anticipated that manufacturers will be able to begin submitting UDI information to EUDAMED. This date shifted from 2021 May per announcement from the European Commission in 2021 March.
  • 2022 May: IVDR DoA (Date of Application) and EUDAMED Launch (all modules complete and released)
  • 2022 May-2023 Nov: EUDAMED Device Registration period of 18 months for Legacy, MDR, and IVDR devices

Overview

Understanding UDI Basics

Understanding Company ID – DUNS & SRN

Understanding Issuing Entities

What is BUDI-DI and How is it used in EU UDI Requirements?

Understanding Product Approval Certification

Learn more about how Reed Tech can provide that ‘last mile of support’ for UDI submissions to Health Authorities

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