Manufacturing site vs manufacturing date symbol

#1
Hi,

Is there a clear requirement regarding the need of the manufacturing site symbol (black plant) vs manufacturing date (white plant) symbol on a Class I medical device?

Currently, we have the black symbol with the legal manufacturer address on our label and the manufacturing date (yyyy-mm-dd). Do we absolutely need to have the white symbol? Devices are sold in US/CAN and EU.

Thank you,
 
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#2
You do not need to use the white DoM symbol per ISO 20417:2021 which was released in April. You can also buy it from the Estonian Standards Store for 25 euros. Document won't let me copy paste, but paraphrasing it says:

International Organization for Standardization. (2021) ISO 20417:2021 Medical devices — Information to be supplied by the manufacturer. https://www.iso.org/standard/67943.html said:
6.1.4 Other Labeling Requirements
a) the label of a medical device ... shall include production controls as applicable
3) the year, month and day by which it is safe to use (aka Expiration Date)
4) the year month and day of manufacture, for a medical device or accessory without a date by which it is safe to use
i) the date of manufacture can be identified by [the white date of manufacture symbol - ISO 15223-1 5.1.3] or [the manufacture symbol - ISO 15223-1 5.1.1]
ii) The date of manufacture may be included in the lot number of serial number
 
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