MDCG 2023-3 Rev 2

The MDCG Guidance for Vigilance was revised again. Practically, there are no relevant changes for manufacturers. Please note that you „must allow 48 hours (equivalent to two weekdays) for receipt of comment on the draft FSN, unless the nature of the FSCA dictates a shorter timescale e.g. in the case of a serious public health threat“ (Question 20 footnote 34).