The EU’s medical device regulations 2017/745 and 2017/746 require that each device placed on the market must be accompanied by a unique device identification (UDI) which shall be used for identification and traceability purposes, this requirement applies to all devices apart from custom-made and investigational devices.
UDI Structure
The product specific UDI is comprised of two parts: the UDI device identifier (UDI-DI) and the UDI production identifier (UDI-PI).
UDI-DI
This portion of the UDI is both specific to the manufacturer and device-group. This is the “access-key” to the UDI database information.
This portion of the UDI is both specific to the manufacturer and device-group. This is the “access-key” to the UDI database information.
UDI-PI
This shall identify the unit of device production and may include the serial number, the lot number, software identification and manufacturing / expiry date. This tracks the specific production series.
This shall identify the unit of device production and may include the serial number, the lot number, software identification and manufacturing / expiry date. This tracks the specific production series.
Both the UDI-DI and UDI-PI may be made available in a numeric or alphanumeric code. Together, they are known as the device’s UDI which shall be displayed on the “UDI carrier”.
Basic UDI-DI
The Basic UDI-DI represents a device-type described as device with the same intended use, risk classification and design and manufacturing characteristics. It will be the key to device-specific information on the Eudamed database.
The Basic UDI-DI will need to be made available on specific documentation (Declaration of Conformity, Summary of Safety and Clinical Performance, Certificates) however it shall not show on the packaging or label of the device.
The Basic UDI-DI will be made up of several elements which shall include reference to the issuing agency, the manufacturer, the device group, and a number of check digits.
Guidance on Basic UDI-DI and changes to UDI-DI
Issuing Entities
In its implementing decision in June 2019, the European Commission (EC) designated 4 issuing entities to operate a UDI assignment system for medical devices:
(1) GS1 AISBL;
(2) Health Industry Business Communications Council (HIBCC);
(3) ICCBBA; and
(4) Informationsstelle für Arzneispezialitäten — IFA GmbH.
(2) Health Industry Business Communications Council (HIBCC);
(3) ICCBBA; and
(4) Informationsstelle für Arzneispezialitäten — IFA GmbH.
Each of the issuing entities use a specific coding system in accordance with their own standards; however, these coding systems are translatable to the EU Regulations requirements on UDI. e.g. GS1 have developed the term Global Model Number (GMN) for the Basic UDI-DI, Global Trade Item Number (GTIN) for UDI-DI, and Application Identifier (AI) for UDI-PI.
It is the obligation of the manufacturer to assign the UDI and place the UDI Carrier on the device label/packaging. The assignment of the UDI shall be done in compliance with the rules set out by the issuing agency chosen.
If you haven’t done so, we suggest that you get in touch with one of the above issuing agencies to begin steps towards complying with this obligation.
Timelines
The obligation to assign the UDI to a medical device shall apply from the date of application of the two EU Regulations.
This means that a UDI will need to be assigned by 26 May 2020 for medical devices and by 26 May 2022 for IVD medical device.
The obligation to submit the UDI data in the Eudamed database will apply from 26 November 2021 for medical devices, and 26 November 2023 for IVDs. Manufacturers may comply with the registration requirements as from the date of application of the regulations. If the Eudamed database is not fully functional before the date of application of these regulations, the obligation date will move to 24 months after the Eudamed database is fully functional.
MDR Requirement |
Class III / Implantable | Class IIa / IIb | Class I |
Placing UDI-carrier on device labels | 26 May 2021 | 26 May 2023 | 26 May 2025 |
Direct marking of reusable medical devices | 26 May 2023 | 26 May 2025 | 26 May 2027 |
IVDR Requirement | Class D | Class C and B | Class A |
Placing UDI-carrier on device labels | 26 May 2023 | 26 May 2025 | 26 May 2027 |