Hi, I know the discussion is a bit old, but here is my response/question:
If you sell in the EU, look at:
MDR GSPR 23.2.
(j) where there is no indication of the date until when it may be used safely, the date of manufacture. This date of manufacture may be included as part of the lot number or serial number, provided the date is clearly identifiable;
MDR GSPR 23.3.: Information on the packaging which maintains the sterile condition of a device (‘sterile packaging’). The following particulars shall appear on the sterile packaging:
(h) the month and year of manufacture,
If you sell in USA, then look at:
§801.40 Form of a unique device identifier.
- (b) The UDI must include a device identifier segment. Whenever a device label includes a lot or batch number, a serial number, a manufacturing date, an expiration date, or for a human cell, tissue, or cellular or tissue-based product (HCT/P) regulated as a device, a distinct identification code as required by §1271.290(c) of this chapter, the UDI must include a production identifier segment that conveys such information.
So that would mean what is on the label, should also be in the UDI. We made the conclusion that, to be compliant with MDR, reusable devices need to have manufacturing date on the label, and pouchlabels of sterile devices need to have the manufacturingdate on the pouchlabel. When we also want to export to the USA, the manufacturingdate should also be included in the UDI for both reusable and sterile devices.
Any other thoughts? Thank you!