Posted By
Amy McKinney
02-May-2019 15:14
Found In
Egroup:
Regulatory Open Forum
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I haven't seen any guidances yet about this specifically, but Annex VI, Part C, paragraph 2 states the following: 2.2. The manufacturer shall assign and maintain unique UDIs for its devices. 2.3. Only the manufacturer may place the UDI on the device or its packaging. However, per 3.10: 3.10. ...
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