Unique Device Identification (UDI)

A worldwide system for unique identification of medical devices is introduced with European regulation (EU) 2017/745 on medical devices and (EU) 2017/746 on in vitro diagnostics (IVDR). It is based on the UDI (unique device identifier), a generic term for product recognition from basic UDI, UDI-DI and UDI-PI. All master data of a product group will be stored in the European medical devices database EUDAMED of the European Commission using basic UDI. The UDI-DI (UDI Device Identifier) is a product identifier that must be assigned to the product itself or its pack. The UDI-PI (UDI Production Identifier) contains product information such as batch number or expiry date.

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 our FAQ.

Detailed information on how to use IFA’s Coding System conform to UDI can be found in the following specifications:
Technical Specification of PPN-Code
PPN-Code Specification for Retail Packaging
IFA Specification Use of the IFA Coding System for medical devices
Specification UDI Use of the IFA Coding System for MD

IFA Sample UDI labels
UDI Labelling


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.

Prerequesite for using the PPN as UDI-DI

Prerequesite for using the PPN as UDI-DI of your medical device and its publication into the IFA Database is signing IFA’s customer contract (IFA-Anbietervertrag).

Via postal mail:

By email to ifa@ifaffm.de:

  • Copy of your company’s trade registry excerpt Handelsregisterauszug or business registration Gewerbeanmeldung

More detailed information on the necessary documents can be found in the New Customers section.

After your company’s successful legitimisation, you will receive a confirmation letter containing your IFA Customer ID (IFA-Kundennummer).

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.
 

IFA-Auftragstabelle A – Zuteilungen or Anlage A – Zuteilungen

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 – Neuaufnahmen Medizinprodukte or

Anlage B3 – Neuaufnahme Medizinprodukte

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.
 

IFA-Auftragstabelle A – Zuteilungen or Anlage A – Zuteilungen

 
Further information on the order notification documents can be found here.

IFA Codingsystem
SecurPharm
Informationsstelle für Arzneispezialitäten – IFA GmbH