IFA GmbH as UDI Issuing Entity

IFA GmbH has been designated as issuing entity for UDI-DI with the Commission Implementing Decision (EU) 2019/939 of 6 June 2019. A Pharmacy Product Number (PPN) coded according to IFA’s Coding System on the pack is thus a UDI-DI conformal with the MDR.

General information on the UDI can be found in the FAQ.

Detailed information on how to use IFA’s Coding System conform to UDI

can be found in IFA Specification Use of the IFA Coding System for medical devices
Specification UDI Use of the IFA Coding System for MD

Determining the complete basic UDI (BUDI) and Health Product Code (HPC):

For determining the complete BUDI and HPC - see also Specification UDI Use of the IFA Coding System for MD - IFA supports the determination of the check digit:

Please note that despite notifying your products to IFA GmbH, you will have to register your packs to EUDAMED, too.

We will inform you about further amendments to the UDI section resulting from the MDR. If you are an existing IFA customer, we will send you an email.

 

FAQ for UDI

Multiple answers to your questions about Unique Device Identification (UDI) and the use of the PPN as UDI-DI, can be found in the lower part of the FAQ

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