EUDAMED Device Registration

As of October 2021, the EUDAMED Device registration module is operational. The manufacturer can already register UDI/Device information in EUDAMED on a voluntary basis.

The registration of legacy and Regulation devices will become mandatory within 24 months after the Commission publishes a notice that EUDAMED is fully functional (immediately in case of incidents!).

What Information Should be Registered?

For each device to be placed on the EU market, manufacturers must enter in EUDAMED the information listed in Annex VI Part A, Section 2 (excluding section 2.2) and in Annex VI Part B MDR/IVDR.

Among others, such information includes:

  • UDI
  • Device class
  • Certificates information (if applicable)
  • Device Information (trade name, model, EMDN code, single-use (y/n), sterile (y/n), clinical size, etc…)
  • Clinical Investigation information (if applicable)
  • Information on medicinal products incorporated within the device (if applicable)
  • Information on human/animal tissues (if applicable)
  • Whether the device was designed by another legal or natural person
  • Member states where the device is first placed on the market and where the device is made available on the market

How to Register Devices

In order to register the device information in EUDAMED, manufacturers must:

  • Ensure the devices comply with the applicable legislation (MDR/IVDR)
  • In the case of non-EU manufacturers, sign a Mandate with the Authorised Representative in accordance with Art.11 MDR/IVDR.
  • Complete the registration as an Actor, in the EUDAMED Actor Registration Module;
  • Enter the device information in the EUDAMED Device Module, following the User-guide provided by the EU Commission.

EUDAMED Verification of UDI/Device Information

Besides the manufacturer obligation, the Authorised Representative must verify the registration of the UDI/Device information in EUDAMED performed by the manufacturer. Do not forget to inform your AR, allowing them to verify the registration!

While the Device registration is not yet mandatory, manufacturers are strongly advised to already enter their device information in EUDAMED. Some Competent Authorities are envisaging to wave the need for Notification in the case of devices that have been already registered in EUDAMED.

And you, have you already registered your devices in EUDAMED? In case you have not initiated your MDR/IVDR compliance process yet contact us today!

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