What is UDI (Unique Device Identification)?

UDI is one small part of a complete revamp of European Medical Device (MDR) and IVD (IVDR) regulations.

European UDI system implements IMDRF UDI guidance throughout Europe

—	Article 27 of MDR

—	Article 24 of IVDR

UDI in MDR

Chapter III – Identification and Traceability of devices

• Article 27 -UDI system
• Article 28 -UDI database
• Annex VI:
  • Part B – core elements to be entered in database
  • Part C – definitions and details of the system

UDI – Main requirements

The Unique Device Identification system (‘UDI system’) described in Part C of Annex VI shall allow the identification and facilitate the traceability of devices, other than custom-made and investigational devices, and shall consist of the following:

(a)

production of a UDI that comprises the following: — a UDI device identifier (‘UDI-DI’) specific to a manufacturer and a device. The UDI-DI is a unique numeric or alphanumeric code specific to a model of device and that is also used as the ‘access key’ to information stored in a UDI database. — a UDI production identifier (‘UDI-PI’) that identifies the unit of device production and if applicable the packaged devices. The UDI-PI is a numeric or alphanumeric code that identifies the unit of device production. The different types of UDI-PIs include serial number, lot number, software identification and manufacturing or expiry date or both types of date.

(b)	placing of the UDI on the label of the device or on its packaging;

(c)	storage of the UDI by economic operators, health institutions and homecare professionals;

(d)	establishment of an electronic system for Unique Device Identification (“UDI database”)

UDI issuing entities

• The European Commission shall designate by means of implementing acts UDI issuing entities provided that they satisfy certain criteria
• Such criteria include:
  • the entity system for the assignment of UDIs is adequate to identify a device through its distribution and use in accordance with the requirements of the Regulation;
  • the entity system for the assignment of UDIs conforms to the relevant international standards;
  • the entity gives access to its system for the assignment of UDIs to all interested users according to a set of predetermined and transparent terms and conditions.
• Until the Commission has designated UDI issuing entities, GS1, HIBCC, ICCBBA shall be considered as designated issuing entities.

Assignment/Submission of UDI data/UDI carrier

• Before placing a device on the market, the manufacturer shall assign to the device and – if applicable – to all higher levels of packaging a UDI.
• The UDI carrier shall be placed on the label of the device and on all higher levels of packaging. Higher levels of packaging do not include shipping containers.
• Before a device is placed on the market the manufacturer shall ensure that the information referred to in Part B of Annex V of the device in question is correctly submitted and transferred to the UDI database
• In some cases, the manufacturer is required to assign a Basic UDI-DI to the device before applying for the conformity assessment (the Notified Body will include a reference to the BASIC UDI-DI in the certificate).

Main features of Basic UDI-DI

• Main key for records in the UDI database
• Declaration of Conformity
• Safety communications (FSN)
• Technical documentation
• Summary of safety and clinical performance
• Device certification issued by Notified Body
• Certificate of free sale

Main deadlines

• UDI assignment and submission of UDI core data elements to the database: date of application of the new Regulations (unless EUDAMED is not functional by that date).
• Placement of the UDI carrier:
  • Implantable devices and Class III devices (and Class D IVDs): 1 year after the date of application.
  • Class IIa and Class IIb devices (Class C and B IVDs): 3 years after the date of application;
  • Class I devices (Class A IVDs): 5 years after the date of application;
  • Reusable devices that shall bear the UDI Carrier on the device itself: 2 years after the date applicable for its respective class of devices.

Additional important aspects

• Legal responsibilities of manufacturers, importers, distributors in relation to UDI
• UDI data elements: the medical device nomenclature in the EU UDI Database
• UDI-PI components: manufacturing date to be included only if it is the only production identifier which appears on the label
• New UDI-DI is required under certain foreseen conditions
• In case of space constraints on the label, AIDC format to be favoured unless devices are intended to be used outside health institutions (HRI)
• Direct marking on the device for reusable devices, with some exemptions
• No ad-hoc exemptions are foreseen
• Specific rules for implantable devices, systems and procedure packs, configurable devices, device software

UDI improves safety

Using a Unique Device Identification (UDI) system based on international guidanceshould significantly enhance the post-market safety of medical devices by:

• Improving incident reporting
• Improve safety corrective actions
• Better targeting of recalls
• Better monitoring by competent authorities
• Reducing medical errors
• Fighting against counterfeit devices
• Improving purchase-policy and stock-management by hospitals

European UDI timelines