IFU - notice to user to report

  • 16 September 2022
  • 1 reply

Annex I, 23.4. Information in the instructions for use

(z) a notice to the user and/or patient that any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established

Is actual practice and expectation to include a canned statement to this effect in every IFU?

1 reply

Userlevel 2

@twhitecentrix Previous places I have worked that is what they did, added that statement to all applicable IFUs and put it at the end of the IFU. They may add some verbiage so its states a specific product or manufacturer (your company).