EUDAMED is the IT system made of 6 interconnected modules developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnosis medical devices.
Actor and user registration and management
UDI database and registration of devices
Certificates and Notified Bodies
Clinical Investigation and performance studies
Vigilance and post-market surveillance
All economic operators are obliged to register. Economic Operators include Medical device Manufacturers, Authorized Representatives, Importers, and System or Procedure Pack Producers. If your company holds more than one of these roles, then registration must be done multiple times to receive SRN for each role.
No matter whether their devices are CE marked in accordance with the directives or the laws that will replace them, the MDR mandates that all medical device actors, including manufacturers, register in the revised Eudamed database as of May 26, 2021. Mandatory registration won’t start right away because the database setup is taking longer than expected. Instead, voluntary registration will start on December 1,2021 and industry preparation is strongly urged.
Actor in the EUDAMED REGISTRATION
Each economic operator in EUDAMED is uniquely identified by their Actor ID/SRN (Single Registration Number). Once the relevant competent authority has approved the Actor registration request, the Actor ID/SRN is issued. When an actor is a manufacturer, authorized agent, or importer of MDR and/or IVDR devices that are registered in accordance with MDR Art 31/IVDR Art 28, EUDAMED generates an actor’s unique identity, known as an SRN. If not, the identification is known as an Actor ID.
MDR and IVDR Requirements for completing EUDAMED Registration.
Once Technical File documentation compilation has been completed, and E.A.R. had been appointed by Non-EU Manufacturer, Registration Process in Eudamed can be commenced. This process is done before appointing Notified body for the assessment as per conformity assessment procedure for high-risk class medical devices.
Obtain basic UDI-DI and the UDIs from the Issuing Entities designated by the EU Commission such as IFA GmbH, GS1, Health Industry Business Communications Council (HIBCC), ICCBBA.
Obtain Single Registration Number by registering as Actor module in EUDAMED.
once economic operators register themselves in Eudamed and obtain SRN after verification from the competent authority, the manufacturer should use this SRN for applying to a notified body for conformity assessment.
For low-risk medical devices and In-Vitro Diagnostic Devices, declaration of conformity serves as the purpose of registration but for the higher class of medical devices, notified body involvement is required for conformity assessments.
How can we help manufactures with EUDAMED Registration?
Assist in providing an official European Authorized Representative who is already registered as Actor Module in Eudamed.
Assist in selecting Competent Authority for both EU manufacturer and Non-EU Manufacturer.
Assist in selecting Notified body for Conformity Assessment for higher class of medical devices.
Assist in preparing Declaration of conformity for low risk of medical devices and In-Vitro Devices.