Is the deadline for UDI compliance extended if the product needs direct marking?

For direct marking requirements the compliance dates are usually extended in compared to the other labelling deadlines (e.g. of 2 years later than other labelling deadline for US FDA and EU UDI requirements), at the exception sometimes of some device classes (e.g. under US FDA UDI rule, for Class II & Class I implants and life-supporting/sustaining devices).

Also, the US FDA does not intend to enforce UDI direct mark requirements under 21 CFR 801.45 when the device’s UDI can be derived from other information directly marked on the device. This applies only to finished class III, LS/LS, and class II devices that are non-sterile, that were manufactured and labeled prior to their established direct mark compliance date, and that remain in inventory.  This is intended to alleviate manufacturers of having to rework finished devices. Please refer to the relevant regulations.