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
- 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