EUDAMED registration: November is around the corner!

EUDAMED Device Registration Support:
We Handle the Entire Process,
No Internal Resources Required

With EUDAMED becoming mandatory from May 2026, manufacturers placing medical devices on the European market must ensure that their products are correctly registered in the database by November 2026.

This requirement applies not only to devices already certified under MDR (EU) 2017/745, but also to legacy devices that will remain on the market until 2028 under the MDR transitional provisions.

For many manufacturers, EUDAMED registration involves much more than simply uploading data into a portal.

A compliant registration requires:

• Accurate UDI management and allocation

• Validation of Basic UDI-DI information

• Consistency between EUDAMED records and technical documentation

• Verification of economic operator registrations

• Coordination with authorised representatives and importers

• Ongoing management of updates and lifecycle changes

The Hidden Challenge

Many manufacturers choose to outsource the registration process to third parties. However, in most cases this still requires significant internal involvement.

Typically, manufacturers are asked to complete complex spreadsheets, populate data templates, verify hundreds of data points, and perform multiple review cycles before the information can be uploaded through manual or automated systems.

As a result, the administrative burden often remains with the manufacturer.

The Maytal Difference

At Maytal, we have developed a different approach.

Our team works directly from your existing technical documentation and regulatory files to extract, validate and prepare all information required for EUDAMED registration.

This means:

✓ No complex spreadsheets to complete

✓ No extensive internal resource allocation

✓ No manual data preparation by your team

✓ Minimal disruption to your day-to-day operations

We review the technical documentation, identify the required registration data, prepare the complete EUDAMED dataset, and manage the registration process on your behalf.

A Fully Managed Service

Our support includes:

• Portfolio assessment and registration planning

• UDI and Basic UDI-DI verification

• Data extraction directly from technical documentation

• Preparation and validation of EUDAMED records

• Device registration within EUDAMED

• Support for updates and future changes

Why Start Now?

Many manufacturers underestimate the effort required to register an entire product portfolio.

Starting early allows organisations to identify missing information, resolve UDI-related issues, and ensure full alignment between technical documentation and EUDAMED records before the November 2026 deadline.

Let Maytal Handle the Process

Our objective is simple: to deliver a compliant EUDAMED registration process with virtually no internal resource commitment from your organisation.

Contact our team today to discuss your device portfolio and build a registration strategy tailored to your business.