Yes, Annex I Section 23.4(z) demands that the IFU contain 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.
This is one of the many new additions compared to the MDD that should be elucidated when performing your EU MDR gap assessment.
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Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
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Original Message:
Sent: 26-Oct-2022 15:29
From: Christopher Chin
Subject: Labeling/ IFU concerning adverse events statement
Is it a mandatory requirement, under European Commission/EU MDR, to include a statement concerning adverse events notice on a manufacturer's IFU? I.e., "any serious incident that has occurred in relation to the device shall be reported to the manufacturer and the competent authority". Your opinion on this is much appreciated.
Thank you,
Christopher Chin