EUDAMED and UDI in Europe: An Overview

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What is EUDAMED?

The European Databank on Medical Devices (EUDAMED) is an IT system developed by the European Commission to increase transparency and improve surveillance of medical devices (and in vitro diagnostics) that are sold within the European Union. It serves a key functional role in the unique device identification (UDI) requirements included in the MDR and IVDR regulations.

This article excerpts from The Ultimate Guide to the EU/IVDR UDI ebook to highlight the specific role and associated requirements that the EUDAMED database plays in the new regulations.

 

Element 4: The UDI Database

The fourth component of the UDI system is entry of UDI and device information into the UDI database through EUDAMED. The MDR and IVDR require manufacturers to register all devices and submit specific information to the database before placing a device on the market. The core data elements provided through the UDI database will be accessible to the public free of charge. The list below outlines all of the required information for device registration.

Annex VI, Part A of 2017/745, states that the UDI database will contain all information about devices presently on the market and discontinued products. The database is designed to allow for linking across all packaging levels of the device. For all devices currently on the market, manufacturers are required to periodically verify the accuracy of the information in the database. If any changes are made to a device that do not require a new UDI-DI, manufacturers must still update the database within 30 days.

Information to be submitted with the device and economic operator registration must include

  1. Economic operator information (2017/745 Annex VI, Part A(1)):
  2. Information relating to the device
  3. Manufacturing information

The tables below outline all of the specific information that must be submitted to EUDAMED:

 Economic Operator Information
  • Type of economic operator
    • manufacturer, authorized representative, importer, distributor, a person who sterilizes systems or procedure packs, an investigator for clinical investigations
  • Name, address, and contact details of the economic operator or of any person submitting information on behalf of the economic operator
  • Name, address, and contact details of person responsible for regulatory compliance
  • Presence of human blood, human plasma, tissues, or cells of human or animal origin
  • Single Identification Number of the clinical investigation

 Information Relating to the Device
  • Information regarding the certificate issued by the notified body
  • Member State in which the device will be placed on the market, and for all class IIa, IIb, or III devices, all Member States where the device will be made available
  • Risk class of the device
  • Whether the device is single-use
  • Whether the device contains any substance which may independently be considered a medicinal product, and name of that substance
  • Presence of human blood, human plasma, tissues, or cells of human or animal origin
  • Single Identification Number of the clinical investigation
  • Whether the device is intended for any non-medical purpose
  • Summary of safety and clinical performance for any class III or implantable devices
  • Status of the device (on market, recalled, discontinued, field safety corrective action initiated)

 Manufacturing Information
  • Quantity per package configuration
  • Basic UDI-DI and any additional UDI-DIs
  • Production information including expiration date or manufacturing date, lot number, serial number
  • The unit of use UDI-DI, if applicable
  • Name and address of the manufacturer
  • The Single Registration Number (SRN)
  • Name and address of the authorized representative, if applicable
  • Medical device nomenclature code
  • Risk class of the device
  • The name or trade name of the device
  • Device model, reference, or catalogue number
  • Clinical size information, including volume, length, gauge, diameter
  • Additional product description, if applicable
  • Storage and/or handling conditions
  • Whether it is a single-use device
  • Maximum number of reuses allowed
  • Whether it is sterile
  • Need for sterilization before use
  • Containing latex
  • URL for any additional information
  • Critical warnings or contra-indications

In addition to this information, the European Commission recently released the UDI HelpDesk. The HelpDesk will provide support to economic operators in the implementation of the obligations and requirements introduced by the new UDI system.

To learn more about EUDAMED and the European UDI system including a UDI overview, formats and issuing entities, implementation timelines, and key differences between the EU and US UDI systems, please register to download the full ebook.

 

Download the full eBook

Rimsys is a world-leading provider of Regulatory Information Management (RIM) software designed specifically for the medical device industry. Rimsys offers a suite of cloud-based regulatory affairs software solutions to simplify and manage global product registrations, standards, essential principles requirements, UDI requirements, regulatory documents, changing regulations and more.

www.rimsys.io