EUDAMED Is Now Mandatory – What MDR Class I and IVDR Class A Manufacturers Need to Do

9/7/20262 min read

EUDAMED is no longer something to prepare for “later”

Since 28 May 2026, the first four EUDAMED modules have been mandatory:

  • Actor registration

  • UDI/Device registration

  • Notified Bodies & Certificates

  • Market Surveillance

Where required under the MDR or IVDR, manufacturers shall register as actors in EUDAMED and obtain a Single Registration Number (SRN).

MDR Class I and IVDR Class A are not exempt

Manufacturers shall register their organisation in EUDAMED and obtain a Single Registration Number (SRN).

Manufacturers shall submit the applicable UDI/Device information to EUDAMED for devices subject to the registration requirements, taking into account any applicable exemptions or special UDI rules. This applies also to Class I medical devices and Class A IVDs.

The UDI/Device information includes, among other things, the Basic UDI-DI, UDI-DI, EMDN code and device characteristics.

28 November 2026 is an important date

For Regulation devices that were already placed on the market before 28 May 2026 and continue to be placed on the market afterwards, the transitional deadline for registration in the UDI/Device module is 28 November 2026.

Where EUDAMED device registration is required, a new MDR or IVDR device shall be registered before it is placed on the market.

Devices that are no longer being placed on the market do not automatically need to be registered merely because they existed before EUDAMED became mandatory. Registration may, however, become necessary later for certain post-market surveillance or vigilance activities.

What should manufacturers check now?

If you manufacture MDR Class I or IVDR Class A devices, check at least the following:

  • Is the manufacturer correctly registered as an Actor?

  • The SRN been issued?

  • Are Basic UDI-DI and UDI-DI identifiers correctly assigned?

  • Is the correct EMDN code used?

  • Have all devices requiring registration been entered in EUDAMED?

  • EUDAMED information shall be kept consistent with the corresponding information in the Declaration of Conformity, labelling and technical documentation, as applicable.

  • Is responsibility defined for maintaining EUDAMED information when products or company information change?

EUDAMED registration should not be treated as a one-time administrative exercise. The information should remain consistent with the manufacturer’s controlled regulatory and technical documentation throughout the device lifecycle.

Sources:

European Commission – UDI/Device registration

European Commission – EUDAMED transition period for devices

Need help reviewing your EUDAMED registration or UDI data?

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