Unique Device Identification (UDI) System: the EU Commission’s FAQ
The two new EU Regulations on medical devices - 745/2017 (MDR) and 746/2017 (IVDR) introduce the Unique Device Identifier System (UDI). Those codes are made of a series of alphanumeric characters that will allow to univocally identify any medical device, except for custom-made and performance study/investigational devices.
The UDI system will facilitate easier traceability of medical devices, significantly enhance the effectiveness of post-market safety-related activities for devices and allow for better monitoring by competent authorities. It will also help to reduce medical errors and to fight against falsified devices. Finally, the use of the UDI system should also improve purchasing and waste disposal policies and stock-management by health institutions and other economic operators.
In August 2020, the European Commission has published a FAQ collecting the most common questions on the UDI System - a document of great help for stakeholders, manufacturers and regulatory specialists working in the medical devices sector.
The Issuing Entities
In the EU Commission Implementing Decision 2019/939 of 6th June 2019, the European Commission has designated the below 4 entities that will be responsible for assigning UDI codes within the European Union:
- Informationsstelle für Arzneispezialitäten (Germany);
- GS1 AISBL (Belgium);
- Health Industry Business Communications Council (USA);
- ICCBBA (USA).
The designations are valid for five years from June 27, 2019; at the end of this period they can be renewed, if the entities will remain compliant with the related/applicable requirements.
UDI-DI and UDI-PI
The UDI is a series of numeric or alphanumeric characters created through a globally accepted device identification and coding standard. It allows the unambiguous identification of a specific medical device on the market.
The UDI is comprised of the UDI device identifier (UDI-DI), specific to a manufacturer, and a device, providing access to the information and production identifier (UDI-PI) that identifies the unit of device production and may include information on the lot or serial number and be able to be applied anywhere in the world.
The UDI Carrier [Automated Identification for Data Capture (AIDC) and human readable interpretation (HRI) representation of the UDI] shall be on the label or on the device itself and on all higher levels of device packaging.
A new UDI-DI shall be assigned every time there will be a modification that could lead to misidentification of the device (as, for example, changes in name, model or label).
The responsibility to comply with UDI-related requirements will lay on the manufacturer and on each person that will assume the obligations incumbent on manufacturers (distributors, importers, etc.), as per Article 16 of MDR and IVDR. Moreover, distributors and importers will have the responsibility to verify that the UDI was assigned to a device.
Comparing to the US UDI system, the EU Law will require manufacturers to assign to their devices an additional code, the Basic UDI-DI, which will be the main key to access the Eudamed database and to identify the device-related documentations, such as free sales certificates, technical documentation and data on clinical performances (for an extensive list of documents where Basic UDI-DI is referenced, look into the Regulations and check the MedTech Europe Guidance for assigning Basic UDI-DI(2020).
The Basic UDI-DI will not appear on the devices’ labels: each Basic UDI-DI will be an identifier for a group of devices with the same intended purpose, risk class, design and manufacturing characteristics.
Deadlines for the application of UDI requirements
The UDI assignment will be applicable from the date in which the two Medical Devices’ Regulations will come into force, i.e. May 26, 2021 for medical devices and May 26, 2022 for in-vitro diagnostic medical devices. The submission of UDI data in the Eudamed database, instead, will be mandatory from November 26, 2022 for medical devices and November 26, 2023 for in-vitro diagnostic medical devices - if Eudamed is functional in May 2021 or 24 months after the date Eudamed became fully functional (expected in May 2022).
As for the obligation of placing the UDI codes on device labels, manufacturers shall observe the following deadlines:
- Implantable and Class III medical devices: May 26, 2021;
- Class II medical devices: May 26, 2023;
- Class I devices: May 26, 2025;
- Reusable implantable, Class III medical devices and Class D IVDs: May 26, 2023;
- Reusable Class II medical devices and Class C and B IVDs: May 26, 2025;
- Reusable Class I medical devices and Class A IVDs: May 26, 2027.
The European Commission will keep updating the FAQ on the Unique Device Identification System and it can be the starting point to understand one of the most interesting aspects of the new EU Regulation on medical devices
Regulatory Affairs Department
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- Official Journal of the European Union. (2019). Commission Implementing Decision (EU) 2019/939 of 6 June 2019 designating issuing entities designated to operate a system for the assignment of Unique Device Identifiers (UDIs) in the field of medical devices. Retrieved on 19/01/2021 from https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32019D0939
- European Commission. (2020). Unique Device Identification (UDI) System under the EU medical devices Regulations 2017/745 and 2017/746. Retrieved on 19/01/2021 from https://ec.europa.eu/docsroom/documents/42641
- Medical Device Coordination Group. (2020). Guidance on Basic UDI-DI and changes to UDI-DI. Retrieved on 19/01/2021 from https://ec.europa.eu/docsroom/documents/34043
- MedTech Europe (2020). MedTech Europe Guidance for assigning Basic UDI-DI. Retrieved on 19/01/2021 from https://www.medtecheurope.org/wp-content/uploads/2020/06/200602_MTE-Basic-UDI-DI-guidance-v1.1_final.pdf