02/2022 - UDI VS UFI - SAY WHAT?
UDI and UFI are unique identifiers which are mandatory for Medical Devices and Dangerous Mixtures respectively.
What it is!
The UDI or “Unique Identification Number” is one of the new codes that originate from the new European Regulations for Medical Devices (EU MDR 2017/745 and IVDR 2017/746).
This ‘UDI-code’ consists in fact of three ‘codes’:
- Basic UDI
- Device Identifier (DI)
- Production Identifier (PI)
The DI and PI should be printed on the labeling of your Medical Device, the Basic UDI not.
Whereas the Device Identifier could just be the GTIN code (assigned by the legal manufacturer of the device and not by the distributor, as in the past), the Production Identifier is more complicated to add to your labeling and may require changes to the (contract) manufacturing site. The DI and PI need to be printed in ‘human readable’ and ‘AIDC’ format, the latter means that the code is ‘scannable’.
Example of a UDI:
The characteristics of the UDI code mentioned on the sales packaging may be impacted by the point of sale for your specific device.
Ultimately, all UDI information will need to be entered by the legal manufacturer in the new Eudamed database. This information will enhance traceability of all devices in the EU, and it will also be used for vigilance tracking.
The deadline for implementing the different steps of UDI coding depends on the classification of your device.
Note: The EU requirements on UDI should not be confused with the UDI legislation for devices in the USA !
The UFI or ‘Unique Formula Identification’ is a unique code that must be assigned to 'dangerous mixtures'. This obligation resulted from a new update of Annex VIII of the CLP Regulation (EU CLP 1272/2008) in March 2017. This is an obligation in every EU member state.
Example of a UFI:
This new code needs to be present on the packaging of ‘new’ hazardous mixtures since the beginning of 2021, BUT there is a transition period until 2025 for products already on the market before that date.
It is commonly known that biocidal products need to carry a UFI code, but did you know that several products for general sale also fall into the scope of ‘hazardous mixtures’, and hence need to implement the UFI code ? How to be sure ? Well, it can be deducted from the MSDS, (Material Safety Data Sheet) of your product.
The UFI and the related formulation must be notified to the National Poison Information Center so it can be used to precisely and quickly find the product information, in order to advise on appropriate measures in the event of an emergency situation (for example misuse or risk of poisoning).
What are the consequences?
Your company should be aware of the requirements for UDI and UFI. You should know for which of your products this is mandatory and from which date onwards.
Are you ready?
Do not hesitate to contact us if you need further information or help on UDI’s and UFI’s ! We are ready to assist you!