Skip to main content

Preventive Health Protection (PHP) and Other Non-Compliance (ONC) procedures

  1. From the dashboard, select the Preventative Health Protection (PHP) measure and click Next. The landing page opens showing the actor (CA) information. EUDAMED generates an identifier containing the abbreviation 'PHP', the country, year and reference:

    EUDAMED choose a procedure type field
    EUDAMED preventive health protection identifier

  2. Establishing the trigger for the procedure and defining the EO(s) is done the same way as for the Unacceptable risk procedure.

  3. You can add more EOs. Click Add another EO and select the actor type from the dropdown. Type in the EO name and select it from the list. If it does not appear, click Enter data manually:

    EUDAMED add another eo link and role field in the popup window
    EUDAMED organisation name field and find button with popup window with list of all economic operators

  4. When the EO is registered, the system retrieves the EO contact information. Enter a contact for this particular procedure:

    EUDAMED fields in the eo contact information section

  5. Identify the device. These steps are the same as for the UNR procedure (see Device information):

    EUDAMED device scope type field in the device information section

  6. You can identify several Notified Bodies (NB) (see UNR, Device information, Step 6). Now create the measure(s) associated to the procedure:

    EUDAMED select notified body field

The procedure can only be submitted when the Measures section has been completed.

If a Manufacturer or Authorised representative referred to in the procedure device is not linked to the Procedure, the following confirmation warning displays:

EUDAMED save, submit and cancel buttons and confirmation window with yes and no buttons
EUDAMED confirmation message after submitting an msu procedure registration

PHP measures