In 2024, the European Database on Medical Devices (EUDAMED) is set to undergo significant changes that will impact the registration and monitoring of medical devices within the European Union. Manufacturers, authorized representatives, and other stakeholders in the medical device industry must familiarize themselves with these changes and make the necessary preparations to comply with the updated regulations and requirements. This article aims to provide detailed insights into various aspects of the upcoming changes to EUDAMED and its implications for stakeholders.
Where to Log-in for Device Registration in EUDAMED
Only manufacturers and System/Procedure Pack Producers have access to register devices in the EUDAMED database. Before submitting device registrations, the following prerequisites must be met:
– Completion of Actor Registration, a crucial preliminary step for the UDI/Device registration process.
– Registration of at least two Local Actor Administrators to the account.
After completing the aforementioned steps, the same EUDAMED username and log-in credentials will be used to access the EUDAMED Home Page. Upon logging in, users can select from the options to “Register a new Basic UDI-DI” for MDR/IVDR CE marked devices, or “Register a legacy device” for MDD/AIMDD/IVDD CE marked devices, as applicable.
Information Required for Registration
Several key details are required to complete EUDAMED medical device registration, including:
– Authorized Representative details, if applicable
– Device classification
– Device Trade Name(s), Model(s), Reference/Catalogue numbers
– CE Certificate details, if applicable
– UDI details: UDI-DI, UDI-PI
– Target market location
– Device characteristics such as single-use, sterile, storage handling conditions, and warnings or contra-indications, if applicable
– Company responsible for design and manufacturing, if not the registered manufacturer
Registration Process Duration
EUDAMED device applications are generally automatically registered unless the Basic UDI-DI information needs to be verified by the Notified Body. The EU Commission’s EUDAMED UDI/Devices User Guide offers detailed step-by-step instructions for the registration process, outlining the scenarios where registration may require confirmation from the Notified Body.
Validity of Registration
EUDAMED medical device and IVD registrations do not expire. Instead, registrations should be modified as needed, reflecting current information. Economic Operators are advised to verify entered data after the first year, and then every two years thereafter.
Custom-made and Legacy Devices Registration
Custom-made devices do not need to be registered in the Devices/UDI module of EUDAMED; manufacturers may be required to notify individual competent authorities on a case-by-case basis, as per the MDR regulations. Legacy devices are subject to EUDAMED registration requirements, even if they are not subject to certain aspects of the MDR/IVDR.
Registration Deadline
The deadline for mandatory EUDAMED registration has been postponed, making use of the system currently voluntary. Stakeholders are encouraged to begin using EUDAMED and populating data in preparation for the eventual mandatory implementation.
Current Registration Requirements
Until EUDAMED becomes mandatory, the registration requirements under the MDD/AIMDD/IVDD continue to apply. It is important for stakeholders to stay informed about the gradual rollout of EUDAMED and the evolving implementation timeframe.
This understanding of the upcoming changes to EUDAMED and its impact on medical device registration ensures that industry stakeholders are well-prepared for the upcoming transition, promoting compliance and continuity within the European market.