Presumably, your question refers to Annex I(23.4)(z) which requires a statement to report serious incidents to the manufacturer and to the Competent Authority, CA.
This is part of the market surveillance system under the MDR. Under the MDD reports would go to the manufacturer only. Now they go to the Competent Authority as well.
You, as the manufacturer, must report serious incidents to the CA following the time requirements in Article 87(1). Presumably, the CA will match them with the corresponding report they receive directly. If there is a mismatch the CA will contact you under Article 87(11).
My recommendation is that you have a procedure in place in the event the CA contacts you. You will want to respond quickly. (You should have procedures to cover the other areas in Article 93 to 100 when the CA may contact you or another economic operator.)
There are two potential issues to consider in the IFU. One is that Annex I says "serious incidents". This is a technical term in Article 2, so you should decide whether your IFU will define it. The second issue is the identification of the CA. Do you want the IFU to include information on where to report? There is a web page that lists all the CAs.
The US does not have a corresponding requirement for the IFU. I recommend you include this as EU only to prevent confusion.
In the US the requirements are in three parts: manufacturer's who receive reports, health facilities who have reportable events, and voluntary public reports. Since all health care facilities in the US have a fully compliant reporting system, there is no need to duplicate the information in the IFU.
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