Issuing of the UDI-DI
Prior to marketing in the German pharmaceutical market
If you wish to receive a PPN as UDI-DI for your medical device prior to its launch (i. e. to use in your catalogue / brochure etc.), the PPN may be pre-allocated and used for the publication of the product data at a later stage in time.
Upon marketing in the German pharmaceutical market
When the product is launched, a publication order of the PPN into IFA’s Information Services is mandatory.
IFA-Auftragstabelle B3 – First Publication Medical Device
Please include product information and CE marking
Without marketing in the German pharmaceutical market
If a certain medical device is not meant to be marketed in Germany, a PPN may still be pre-allocated to this medical device in the light of delegated regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR). In this case no order is placed for publication of the PPN to IFA GmbH in its relevant Information Services for Germany. The unique encoding of the medical device and its worldwide identification through the centralised PPN issuing are guaranteed in any case. For pre-allocated PPNs without publication in IFA’s Information Services § 5 of IFA’s Supplier Contract does not apply. Obligations resulting from § 7 par. 7 of IFA’s Supplier Contract for PPN pre-allocations applies for countries in which the medical device is marketed.
Further information on the Notification Order Documents can be found here.