👉 26 November 2026 → Your ‘legacy’ devices, under MDD Directive 93/42, must be registered in EUDAMED.
It is important to highlight that many manufacturers/importers mistakenly believe that the process is automatic or that their Notified Body (NB) or Authorised Representative (EC REP) will take care of it. In practice, the manufacturer is the only legal entity responsible for ensuring the integrity and submission of its UDI data. For most organisations, the greatest challenge will be the complexity of preparing the device data, documentation and internal processes required for a successful registration.
👀Registration in EUDAMED is more complex than many expect
At first glance, EUDAMED appears to be simply a centralised database for the registration of medical devices. In practice, however, it is a highly structured system with specific roles and responsibilities that require data coordination across multiple regulatory modules.
The following data are required:
✔️Actor registration and Single Registration Numbers (SRN)
✔️Unique Device Identification (UDI) data
✔️Device master records
✔️Notified body certificate information
✔️Regulatory documentation aligned with the MDR or the IVDR.
In short:
⚠️MeDev Consulting: Your trusted regulatory partner
With the EUDAMED deadlines fast approaching, it is essential to act quickly and ensure that your regulatory submissions are fully prepared and compliant. MeDev Consulting works with medical device manufacturers to simplify the complex regulatory landscape.
We offer personalised assistance and structuring of device data, through to the validation of complex regulatory documentation and the management of every stage of your EUDAMED registration.
By drawing on our proven experience, you can avoid costly mistakes, eliminate last-minute stress and confidently secure your position in EU markets.
⏳Do not wait until the deadlines are upon you: contact us today to access flexible, end-to-end solutions for EUDAMED management.
👉 There is no time to lose. It is essential to complete registration in the UDI/DEV module as soon as possible to avoid operational disruption and non-compliance risks.
⚠️✔︎ For strategic regulatory consultancy, training and direct support in using the EUDAMED modules, the experts at MeDev Consulting are at your side. Contact us at: info@medev.es
REFERENCES: