The European Commission started its traceability system with the release of the Commission Recommendation Document (EU) 2013/172 on 05 April 2013. It followed up with Regulation (EU) 2017/745, which provided extensive information about sale and inspection of clinical and medical devices for human use.
In addition, the European Commission has developed a central database called EUDAMED. Using this, medical device suppliers, importers, authorized representatives, and third parties can examine medical device reports and decide on their own device classes. They can upload and report medical device information to the database with the same actor they created.
Below you can find answers to the most common Unique Device Identification (UDI) questions that we have received from our clients.
- What is Unique Device Identification (UDI)?
UDI is a unique numeric or alphanumeric code that is used for identifying and tracking medical devices throughout their use and distribution while ensuring information transparency.
Manufacturers and importers of medical devices, as well as their authorized representatives, can place a UDI on the device or its packaging. In re-usable devices, labels need to be located on the device rather than on the packaging. Manufacturers are obliged to keep an updated list of all UDIs they have allocated. UDI are readable by both humans and machines and meet global standards.
2. When will the obligation start?
Deadlines have been published by the European Commission. The type and class of the device and placement of the labels may vary, as follows:
EU MDR (Medical Device Regulation) Placing UDI-carriers on the labels of devices (EU MDR Article 123(3)(f), Article 27(4)):
- May 2021 for Implantable and Class III devices (high risk)
- 26 May 2023 for Class II A (moderate risk) and Class II B (moderate to high risk) devices
- 3. 26 May 2025 for Class I devices (low risk)
Direct marking of 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 II A and Class II B 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 (high risk) IVDs
- 26 May 2025 for Class C (moderate risk) and Class B (moderate to low risk) IVDs 26 May 2025
- 26 May 2027 for Class A (low risk) IVDs
3. Who is responsible?
Medical device manufacturers, distributors, importers, and other legal entities must accept the obligations under the regulation and fulfill all related responsibilities.
4. Which types of devices need to be registered?
Devices fall under one of two regulations: the Medical Device Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR).
These two regulations are split into the following subcategories:
The four classes covered by the MDR are:
- Class III (high risk) products are important to sustaining or recovering patient life, such as brain spatulas and pacemakers
- Class II A products have a moderate risk to patient life
- Class II B medical devices have moderate to high risk
- Class I devices have low risk to human life and have no sterilization or no measuring function. If they have sterilize and a measuring function then devices have medium to low risk to human life.
The four classes covered by the IVDR are:
- Class D devices have a high impact on perserving or recovering human life. Influence on human life decreases as classes change.
- Class C has a moderately high patient or public-health risk
- Class B devices have moderate patient and/or low-public health risk
- Class A devices have low risk to patients and public health
5. Which countries are integrating this regulation into their own systems?
The obligation to label medical devices has spread to a lot of countries, including all European countries, the Kingdom of Saudi Arabia, Turkey, the United States, Australia, Taiwan, South Korea, China, Singapore, and Brazil. The timelines and classes of different medical devices may vary.
Additionally, each country has one or more than one authority that manages and tracks the process and has its own database. For example, in the US the Food and Drug Administration (FDA), in Turkey Türkiye İlaç ve Tıbbi Cihaz Kurumu (TİTCK), and in KSA the Saudi Food and Drug Authority (SFDA) manages the process.
Obligated entities and medical device suppliers can access EUDAMED or their own country’s database to upload or download device data and follow the approval process.
For more information about the process and our related solutions, please contact us at firstname.lastname@example.org.