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Economic operator information

At least one EO must be identified. Note the system message before proceeding:

EUDAMED message: Fill in the mandatory field(s) and click on the 'Check registry' button to add an economic operator. For MDR Art 95 and IVDR Art 90 procedures, every device referenced in the given procedure must be linked to at least one economic operator with the role 'Manufacturer'. Manufacturers of registered devices will be retrieved by the system, but manufacturers of non-registered devices must be specified by the user, or it must be specified that the manufacturer(s) of the given device is unknown.

If you know the Actor ID/SRN, click the box and enter at least five characters. Click Find and select the intended EO:

EUDAMED actor id/srn field with find button and list of economic operators

The system pre-populates the EO information fields, and the EO contact information can be edited. If you register new contact information, it only relates to this Market Surveillance procedure. You can change your choice of EO by clicking Change economic operator and follow the same steps:

EUDAMED fields in the economic operator information section and change economic operator link

  1. If the EO is not registered, enter the data manually.

    1. Provide a unique EO identifier (up to 20 characters), which is used when linking a device to it.

      EUDAMED fields in the economic operator information page and change economic operator link

  2. While a Distributor is not an actor in EUDAMED, it can be linked to a procedure. Select Distributor, type in the Distributor name and click Find. As no result will be shown, click Enter data manually and complete the distributor information:

    EUDAMED role and organisation name fields and find button
    EUDAMED enter data manually button and the fields to fill in when clicking on it

  3. To add additional EOs, click Add another EO:

    EUDAMED fields in the eo contact information section and add another eo link
    EUDAMED list with economic operators with an arrow to view further details

  4. Every EO must be linked to at least one device (see Device information). This could be ensured by linking EO(s) to the device in the device section. Manufacturers and Authorised Representatives of the registered device are linked automatically.

    EUDAMED is this device linked to another economic operator field in the manufacturer information section

Note

On submission, if a Manufacturer or Authorised Representative referred to in the procedure Device is not linked to the Procedure, the confirmation warning displays.

EO contact information fields are automatically populated when submitted a procedure or the new version of the procedure:

EUDAMED confirmation message with yes and no buttons