The following FAQ (Frequently Asked Questions) consist of recurring questions to IFA GmbH. They are grouped under a topic and followed by their answer. If your question is not mentioned, please do not hesitate to contact us directly.
UDI (Unique Device Identification) is a system to uniquely identify medical devices worldwide according to Article 27 of the MDR (Regulation (EU) 2017/745 dated 05.04.2017). UDI is the broader term for a unique product identification consisting of the Device Identifier (UDI-DI) and the Production Identifier (UDI-PI). These items are described in Annex VI, part C of the MDR.
The basic UDI (BUDI) is the main key for grouping those products of a manufacturer that have the same properties. According to the guideline “MDCG 2018-1 Guidance on BASIC UDI-DI and changes to UDI-DI”, these properties include the intended purpose, risk class, essential design and manufacturing characteristics. With the help of the basic UDI and via the databases, the joint reference to the products with regard to the documentation, specifically to the certificates, is to be created.
In principle, the basic UDI is composed of the following four elements (substring elements):
- Issuing Agency Code (IAC)
- Manufacturer Code
- Device Group Code
- Check Digit
The basic UDI is generated by the manufacturer itself. For this purpose, the manufacturer forms product groups according to the above mentioned MDCG 2018-1 Guidance and denotes the Device Group Code for them. The method and further elements are described in the Specification Unique Device Identification (UDI). IFA GmbH provides the manufacturer with a BUDI Generator to calculate the check digit.
The basic UDI is not applied to the package and is not stored in the IFA database.
The UDI-DI (UDI Device Identifier) is a unique product identifier, which is assigned to the product itself or its packaging. For the use of the IFA Coding System, the PPN is used as the UDI-DI. The PPN represents the PZN in an internationally unambiguous format. When issuing a PZN, IFA also issues the PPN at the same time.
Depending on the requirement for a medical device, the manufacturer determines the UDI-PI for his product and labels the packages accordingly. The UDI-PI can be the batch number, expiry date and, in certain cases, also the production date or a serial number assigned by the manufacturer. This applies also for reusable medical devices that are to be refurbished. For these common data elements, the internationally standardised data identifiers in accordance with the international standard ANSI MH 10.8.2 can be used. The IFA Coding System references this standard.
The EU Commission shall set up a central database (EUDAMED) for medical devices according to Article 28 MDR.
With the date of the MDR's application on 26.05.2021, a UDI-DI must be assigned to each medical device. For in vitro diagnostic medical devices, this goes from the application of the IVDR (delegated act (EU) 2017/746 for in vitro diagnostics dated 05.04.2017) on 26.05.2022. An exception to this are custom-made devises and investigational devices. IFA, designated by the EU Commission as UDI-issuing entity on 06.06.2019, enables you to use PPNs as UDI-DIs. IFA's Specification UDI Use of the IFA Coding System for MD and PPN-Code Specification for Retail Packaging describe how the PPN serves as product identification called for by the MDR.
Depending on the class of the medical devices, the UDI carriers must be placed on the label within one to 5 years from 26.05.2021 according to Article 123 (3) point f MDR. See FAQ No 6. of EC's document "Unique Device Identification (UDI) System under the EU Medical Device Regulations 2017/745 and 2017/746" for details. IFA's Specification UDI Use of the IFA Coding System for MD and PPN-Code Specification for Retail Packaging describe how the IFA Coding System serves as product identification called for by the MDR.
A published or pre-allocated PZN can be used uniquely identifying worldwide in the form of the PPN as UDI-DI. This way, the PZN is eligible for registration in EUDAMED.
In accordance with the requirements regarding certain medical devices the manufacturer defines the characteristic(s) suitable for product traceability.
The EU Commission informs on its website that the various modules for voluntary use will be made available step by step. Current information can be found here: https://ec.europa.eu/health/md_eudamed/overview_en. Date of application of the MDR remains 26.05.2021.
IFA GmbH has implemented a data field in which to report an UDI-DI. The UDI-DI of a different issuing entity can also be entered there.
No, because IFA guidelines already concur with the MDR. Please note that Appendix VI of the MDR calls for special issuing rules for UDI-DIs.
Yes, because your product data will not be forwarded to EUDAMED by IFA GmbH.
The UDI-DI (PPN) and the manufacturer's determined UDI-PI have to be included in compliance with IFA's Coding System in the Data Matrix Code. Any other data elements may be, but are not obliged to be, included in the Data Matrix Code.
No, the Basic-UDI does not appear in plain text or in the code. It is used in EUDAMED, certificates and documentation as a key for grouping products.
The manufacturer has to contact one of the issuing entities named by the European Commission. IFA GmbH is one of these issuing entities.
The manufacturer assigns the UDI-PI in accordance with the requirements of the MDR regarding traceability (cf. IFA Specification UDI).
Annex I, Chapter III No. 23.2. point i) MDR requires an unambiguous indication of the time limit for using the device safely. It includes at least the year and month, where this is relevant. In the code, the date format YYMMDD is provided.
No, the manufacturer decides according to QM-specifications if he expresses the date of manufacture in days or months. In the code, the date format YYYYMMDD is provided.
Currently, these products usually bear an EAN code. The PZN is usually in clear print and additionally encoded in Code 39. For MDR conformity, these products must bear the DMC in accordance with PPN-Code Specification for Retail Packaging.