Unique Identification Number (UDI)
The EU MDR mandates the use of a Unique Device Identification (UDI) system which will allow the identification and facilitate the traceability of devices
It can be implemented by establishing an electronic system for the Unique Device Identification (UDI Database).
Place the UDI on the label of the device or on its packaging
Make it appear on the EU Declaration of Conformity.
Should keep up-to-date lists of all the UDIs that has been assigned.
Register the device – the manufacturer should assign a Basic UDI-DI to the device and shall provide it to the UDI database together with the other core data elements related to that device.
Register themselves – Before placing a device on the market, manufacturers should in order to register, submit to the electronic system, if they have not already registered. In cases where the conformity assessment procedure requires the involvement of a notified body, the information shall be provided to that electronic system before applying to the notified body.
The Unique Device Identification (UDI) system consist of.
Unique Device Identification (UDI) number is a set of alphanumeric or numeric characters created through internationally accepted identification and coding standards that would allow distinct identification and traceability of specific devices in the market.
The UDI is comprised of Device Identifier UDI-DI (specific to a manufacturer and a device) and Production Identifier UDI-PI (specific to the unit of device production and the packaged devices).
Both Device Identifier (UDI-DI) and a Production Identifier (UDI-PI) elements
Primary Identifier of a device model
provides link to UDI database.
Referenced in relevant certificates and declaration of conformity
System means either packaged together or not which are intended to be inter-connected or combined to achieve a specific intended purpose. E.g. X-ray system
The Producers at the disposal of the competent authorities, after the system or procedure pack has been put together must declare that
They have verified the mutual compatibility of the devices and if applicable, other product with IFU
They have packaged the systems or the procedure with adequate supply of user instructions about the devices that have been put together
Appropriate validation, monitoring and verification have done on the activity of combining devices.
Numeric or alphanumeric code that identifies the unit of device production.
Includes serial & lot number, software ID and manufacturing & expiry date or both types of date
Referenced in relevant certificates and declaration of conformity.
Application of the UDI on the label of the device or on its packaging;
Recording of the UDI by economic operators, health institutions and healthcare professionals.
Establishment of an electronic system for Unique Device Identification (UDI database).
The UDI data will be registered on the EUDAMED database.
EUDAMED registration permitted before CE Certification. What is the procedure?
Referring articles 29, 30 and 31, before the devices that are subjected to the CA procedure, the manufacturer should assign a basic UDI-DI and provide it to the UDI database. The Notified body will add a reference of the basic UDI-DI in the certificate issued and will check the EUDAMED whether the information added are correct or not.
The manufacturer should keep the information updated thereafter in the EUDAMED. Now regarding the registration of manufacturers, the competent authority will be providing a Single Registration Number (SRN) to the manufacturer upon the registration at an electronic system managed by the MDCG, and the manufacturer should approach the NB with the SRN for accessing the EUDAMED and for conformity assessment, which indicates that both procedures are done before getting the CE certificate.
Who is issuing the UDI – DI?
UDI-DI issued by the ‘issuing entities’ designated by the EU Commission by means of implementing acts. The manufacturer then assigns the UDI to the device and all higher-level packages (except shipment container) before placing them on the market, in compliance to the rules of the issuing entity. Some UDI issuing entities are GS1, HIBCC, ICCBA
What should manufactures do for that?
Manufacturer has to apply for the UDI to the issuing entity designated by EU commission and the UDI has to be submitted to the UDI data base with the details of all the packaging levels too. Appropriate procedure has to be maintained for the validation of the data. They have to periodically verify the correctness of all the data to the devices placed in the market and is being available for use.
Any change in the below details of the device requires new UDI-DI
- name or trade name,
- device version or model
- labelled as single use
- packaged sterile
- need for sterilization before use
- quantity of devices provided in the package
- critical warnings or contra-indications
Other than above changes the device doesn’t require new UDI-DI and the manufacturer has to update the UDI data base within 30 days of the change being made to the element.
The UDI of an implantable device should be at the lowest level of packaging and should be identifiable before implantation. Reusable devices that require cleaning, disinfection, sterilisation or refurbishing between uses UDI should be placed on the device and readable after each process. Configurable devices should bear configurable device UDI. The systems and procedure packs the UDI carrier be affixed on the outside of the packaging with some exceptions.
How to implement UDI?
The EU commission will designate one or several issuing entities to operate a system for the assignment of UDI based on the Regulation. Manufacturer has to assign the UDI with the help of the issuing entity.
The assigned UDI has to be submitted in the UDI database by the manufacturer. Any updates in the identifying information and other device data elements have also to be updated in the database. Before placing the devices other than custom made and investigational devices, the manufacturers has to affix the UDI on the labels or on the device itself and on all higher level of packaging.