The next important EUDAMED deadline is approaching.
By 28 November 2026, manufacturers must ensure that applicable legacy devices and other devices covered by the transitional registration requirements are registered in EUDAMED. Is your organisation prepared?
Since 28 May 2026, the use of four EUDAMED modules has become mandatory under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR).
EUDAMED, the European Database on Medical Devices, is designed to improve transparency, traceability and access to information about medical devices and IVDs on the European market.
Which EUDAMED modules are mandatory?
The following four modules became mandatory on 28 May 2026:
- Actor Registration: Registration of relevant economic operators, including manufacturers, authorised representatives and importers.
- UDI/Device Registration: Registration of medical devices and IVDs, including applicable device identification information.
- Notified Bodies & Certificates: Information about notified bodies and certificates issued under MDR and IVDR.
- Market Surveillance: Used by competent authorities and the European Commission for market surveillance activities.
The remaining modules, covering Vigilance and Post-Market Surveillance, and Clinical Investigations and Performance Studies, are not yet mandatory.
28 November 2026: An important deadline for legacy devices
Manufacturers should pay particular attention to the upcoming registration deadline.
By 28 November 2026, applicable devices, including legacy devices placed on the market before 28 May 2026 and continuing to be placed on the market from that date, must be registered in the UDI/Device module.
Legacy devices are products that continue to be placed on the market under the transitional provisions of MDR or IVDR.
Registration requirements depend on the device’s regulatory status and circumstances. Manufacturers should therefore review their portfolios to identify which products require registration and ensure that the necessary information is available.
Three things manufacturers should check before the deadline
With the 28 November deadline approaching, manufacturers should take the opportunity to review their EUDAMED registration status. Here are three important areas to consider:
1. Identify which devices require registration
Review your device portfolio and determine which products are covered by the upcoming deadline. Pay particular attention to legacy devices and products placed on the market before 28 May 2026 that continue to be placed on the market after that date.
Remember that certain exceptions may apply, including when the corresponding MDR/IVDR-compliant device is already registered in EUDAMED.
2. Check that your registration information is complete and accurate
Make sure your organisation has completed the necessary actor registration and that the required device information is available.
Depending on the device, this may include UDI identifiers, EMDN codes, certificate information and other relevant regulatory data. For legacy devices, specific identification requirements apply.
3. Review your internal responsibilities and registration process
Who is responsible for preparing, verifying and submitting the information? Are the relevant teams aligned, and is there a clear process for maintaining the data?
Establishing responsibilities and reviewing the information before submission can help avoid errors, delays and unnecessary rework.
How can GBA Key2Compliance support you?
EUDAMED registration can raise questions about regulatory requirements, device identification and how to manage registration information across your product portfolio.
At GBA Key2Compliance, our experienced Regulatory Affairs and Quality Assurance consultants can help you turn these requirements into practical actions.
We can support you in several ways:
- Clarifying your obligations:
Understanding which registration requirements apply to your organisation and devices, including legacy products and relevant deadlines. - Preparing for registration:
Identifying the information and documentation needed and helping you address any gaps before submission. - Supporting the registration process:
Providing regulatory guidance and hands-on assistance with applicable actor and device registration activities. - Reviewing your existing registrations:
Helping you identify inconsistencies, missing information or areas that may require attention. - Building a sustainable approach:
Advising on responsibilities and processes for keeping registration information accurate and up to date.
Whether you need guidance on a specific requirement or support throughout the registration process, our consultants can adapt their involvement to your needs.
Need support with EUDAMED registration?
The 28 November deadline is approaching. Are you confident that your devices are ready?
Our experts are ready to help you understand the requirements and take the next steps.
Contact GBA Key2Compliance to discuss your EUDAMED registration needs →