What is UDI (Unique Device Identification)?
It is a unique device identification system created and regulated by the countries’ relevant administrations, which is used and planned to be used in various countries such as the USA, EU, China, Turkey and KSA. For instance, in the US, the process is managed by the Food and Drug Administration (FDA); in Turkey, Türkiye İlaç ve Tıbbi Cihaz Kurumu (TİTCK) and in KSA, Saudi Food & Drug Authority (SFDA). Different platforms and traceability mechanisms have emerged with the regulations published by the country’s internal systems. The basic purpose is to be able to identify and track medical devices appropriately throughout their use and distribution and ensure information transparency.
Only the manufacturers can place an UDI (Unique Device Identifier) on the device or its packaging. Manufacturers are obliged to keep the updated list of all UDIs they have allocated. After full implementation, most medical devices, instruments and diagnostic equipment will contain unique device identifiers (UDI) that can be readable for both humans and machines. In some cases such as reusable devices, these UDI labels can not only be found on packaging but also on the device. The UDIs to be assigned to medical devices must meet the global standards.
The European Commission started to establish this traceability system by publishing the Commission Recommendation Document (EU) 2013/172 on 05 April 2013 and the developments are continuing. Most of the European and Non-European countries follow the EU MDR standards such as Turkey. In the US, FDA introduced the UDI system in 2013 and all medical devices and software included in 2020.
Timeline of the UDI regulation for US, EU, KSA and TR
EU – European Database for Medical Devices (EUDAMED)
EUDAMED is a database developed for the implementation of the EU Medical Device Regulation and the In Vitro Diagnostic Medical Device Regulation. EUDAMED has a public website and six different modules such as registration of Actors, UDI/Device registration, notified Bodies and Certificates, clinical Studies and Performance Studies, vigilance and Post-Market Surveillance and market Surveillance.
As of the deadlines may change type of the device and place of the label can be found below;
” EU MDR (Medical Device Regulation) Placing UDI-carriers on the labels of devices ( EU MDR Article 123(3)(f), Article 27(4)):
- 26 May 2021 for Implantable and Class III devices
Devices which are classified in Class III (high risk) have a huge impact on sustaining or recovering human life. For example brain spatulas, and Pacemakers.
2. 26 May 2023 for Class IIa and Class IIb devices
Class IIa have a moderate risk to human life but class IIb medical devices have moderate to high risk.
3. 26 May 2025 for Class I devices
Class I devices have no sterilization or no measuring function (low risk) and also include devices that have sterilize and a measuring function (low/medium risk).
Direct marking of the reusable devices (EU MDR (Medical Device Regulation) Article 123(3)(g), Article 27(4)):
- 26 May 2023 for Implantable and Class III devices
- 26 May 2025 for Class IIa and Class IIb devices
- 26 May 2027 for Class I devices
IVDR (In Vitro Diagnostics Regulation) Placing UDI-carriers on the labels of devices (IVDR Article 113(3)(e), Article 24(4)):
- 26 May 2023 for Class D IVDs
Class D devices have a high patient risk and high public health risk.
2. 26 May 2025 for Class C and B IVDs 26 May 2025
Class B devices have moderate patient risk and/or low public health risk
Class C have high patient risk to moderate public health risk
3. 26 May 2027 for Class A IVDs
Class A devices have low patient and public health risk.
US – Global Unique Device Identification Database (GUDID)
The Global Unique Device Identification Database was created by the FDA, abbreviated as GUDID. It is the identification system for medical devices sold in the USA, from manufacture to distribution to patient use, it contains all the necessary information. It is also an important resource for both manufacturers and users as it is open to the public.
1) 24/09 /2014 for Class III devices
Devices included in Class III are of paramount importance in preventing the deterioration of human health that supports or sustains human life. Additionally, they need pre-market approval (PMA).
2) 24/09/2016 for Reusable class III devices, class II devices,
Class II medical devices which have medium risk to human life such as pregnancy test kits, powered wheelchair. 510(k) Premarket Notification is required.
3) 24/09 /2018 for Reusable class II devices, class I and unclassified devices,
Class I medical devices which have low to moderate risk to human life and need general controls.
4)24/09 /2020 for Reusable class I devices
KSA – Saudi DI
The Kingdom of Saudi Arabia has its own database named Saudi-DI which is developed by Saudi Food & Drug Authority (SFDA). All medical devices intended for the Kingdom of Saudi Arabia market that are not exempt from UDI (Unique Device Identifier) regulation must be reported and labeled prior to placing on the market. In general, it has been stated that although the standards determined and presented by EUDAMED will be used, there may be minor differences.
Below you can see the obligation timeline to place labels on devices or their packaging;
1) 1st September 2023 for class B, C (medium risk) and D devices (high risk)
2) 1st September 2024 for class A devices (low risk)
Turkey – Türkiye İlaç ve Tıbbi Cihaz Kurumu (TİTCK)
In Turkey, UDI (Unique Device Identifier) is regulated with “Medical Device Regulation” and “In vitro Diagnostic Medical Device Regulation” in full compliance with (EU) 2017/745 Medical Device Regulation. Manufacturers, authorized representatives and importers are required to register in the EUDAMED database.
The devices are classified as class I, IIa, IIb or III, taking into account the risks involved due to their intended use and structure.
” MDR (Medical Device Regulation) Placing UDI-carriers on the labels of devices ( MDR Article 123(3)(f), Article 27(4)):
- 26 May 2021 for Implantable and Class III devices
- 26 May 2023 for Class IIa and Class IIb devices
- 26 May 2025 for Class I devices
Direct labeling of the reusable devices ( MDR (Medical Device Regulation) Article 123(3)(g), Article 27(4)):
- 26 May 2023 for Implantable and Class III devices
- 26 May 2025 for Class IIa and Class IIb devices
- 26 May 2027 for Class I devices
IVDR (In Vitro Diagnostics Regulation) Placing UDI-carriers on the labels of devices (IVDR Article 113(3)(e), Article 24(4)):
- 26 May 2023 for Class D IVDs
- 26 May 2025 for Class C and B IVDs 26 May 2025
- 26 May 2027 for Class A IVDs
Components of Unique Device Identifier (UDI)
UDI is a unique numeric or alphanumeric code, consisting of two components called PI and DI.
- UDI-DI (Device Identifier): It is the first part of the identifier that is specific to the manufacturer and the device information. Provides access to the data about the device in the UDI database.
- UDI-PI (Production Identifier): Second part of the identifier which includes the device production information and packaged devices if any, and includes serial number, lot number, software version for medical device software, and manufacturing and/or expiry date.
Below you can see how it should look visually on the device or in its package.
Both The US FDA and EU EUDAMED are not responsible for managing and generating Unique Device Identifiers (UDI). There are certified international authorities who issue UDIs for MD (medical devices) and IVD(In vitro devices). You can find the most popular four authority below;
- GS1 (Global Standards)
- HIBCC (Health Industry Business Communications Council)
- ICCBBA (International Council for Commonality in Blood Banking Automation)
- IFA GmbH (Informationsstelle für Arzneispezialitäten)
Benefits of labeling Medical devices
With this medical device tracking system, the following are aimed;
- Reporting adverse events related to devices,
- To be able to make recalls for withdrawal from the market or repair, control, adjustment operations
- Prevention of incidents associated with misuse
- Facilitating stock tracking and order arrangements
- Facilitating the product-patient matching
- Ability to perform reporting and statistics
- Effectively combating fraud
- Maintaining brand reputation
- Increasing efficiency in production, storage and distribution operations
- Complying with national and international regulations
How can SNI help you?
SNI add-on solution helps you to get the relevant information from the SAP Master Data, map and process the data in order to convert it into the defined XML file format. SNI add-on also enables the communication with relevant Authorities to receive the final UDI and brings it to the SAP system. The final UDI will be also delivered to the relevant authorities for archiving purposes.
