MDR/IVDR UDI (Unique Device Identification)

 UDI is series of numeric or alphanumeric characters which are designed by globally accepted device identification and coding standard

UDI is used for the identification and facilitate the traceability of devices. Only manufacturer shall place the UDI on the label of the device or on its packaging. Higher levels of packaging shall have their own UDI. Shipping container doesn’t require any UDI.

UDI is used for reporting serious incidents and field safety corrective actions in accordance with Article 87.

UDI comprises two parts,

·      UDI-DI (Device Identifier) specific to a manufacturer and a device. Access key to information stored in UDI database

·     UDI-PI (Production identifier) identifies the unit of device production and if applicable the packaged devices, requirements are mentioned in Part C of Annex VI. Different types of UDI-PIs include serial number, lot number, software identification and manufacturing or expiry date or both types of date.

 UDI is conveyed through UDI carrier by using AIDC (Automatic identification and data capture) and / or Human Readable Interpretation (HRI). Examples of UDI carrier is linear bar code, 2D/Matrix bar code, RFID.

Reusable devices shall bear an UDI carrier on the device itself. After reprocessing of reusable devices (cleaning, disinfection, sterilisation or refurbishing between patient uses) UDI carrier shall be permanent and readable.

MDR ONLY:Direct part marking of UDI on Reusable devices are exempted when this marking is affecting the safety or performance of the device; or if this marking is not technologically feasible.

It shall be readable during normal use and throughout the intended lifetime of the device.

Basic UDI:

·       Primary identifier of a device model.

·       DI assigned at the level of the device unit of use.

·       Linked with UDI database and referenced in relevant certificates and EU declarations of conformity.

Unit of Use DI:

This is used to associate the use of a device with a patient in instances in which a UDI is not labelled on the individual device at the level of its unit of use, for example in the event of several units of the same device being packaged together.

When new UDI is required:

The following UDI database data elements change may trigger a 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 a package

·       critical warnings or contra-indications: e.g. containing latex or DEHP.

The following device software change may trigger a new UDI-DI:

·       new or modified algorithms

·       database structures

·       operating platform

·       architecture or new user interfaces or new channels for interoperability

UDI Database:

Manufacturer shall submit all core UDI database data elements referred to in Part B of this Annex (UDI-DI). see below figure.It shall not include any UDI-PIs and no commercially confidential product information.

UDI requirements are covered in MDR ANNEX VI Part B & Part C, Article 27 & 28/ IVDR ANNEX VI Part B & Part C, Article 24 & 25.

Source:

REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU