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 Services 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
Economic operator information (2017/745 Annex VI, Part A(1)):
Information relating to the device
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)
Read More About: single registration number services
Manufacturing informatione
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
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