The Unique Device Identification (UDI) system defines the provenance of a medical device and tracks it through the healthcare system. From the manufacturer to the import or export of a device, and onwards to the facilities that use it and the patients themselves, the UDI provides a clear and transparent explanation of the product’s source, journey and efficacy.
This ability to accurately trace and track a medical device throughout the healthcare system is at the core of an ongoing agenda to reform regulations and improve both patient safety and the reputation of the medical device industry.
In the EU, the UDI will:
- Provide the traceability of devices.
- Enhance the effectiveness of post-market safety-related activities.
- Improve incident reporting.
- Provide targeted field safety and corrective actions.
- Improve monitoring by competent authorities.
- Reduce medical errors.
- Prevent against fake devices.
- Improve purchasing, waste disposal policies and stock-management by health institutions.
The components
The UDI is made up of a unique label from the manufacturer, data entries related to the manufacturer and information on the product or packaging. It is a series of numeric or alphanumeric characters generated by an international coding standard, enabling the totally unambiguous identification of a specific medical device on the market. The subsequent UDI barcode is a system that then encodes both the device identifiers (DI) and production identifiers (PI), supplemented by a centralized database.
In the EU, the most important component of the UDI is the basic UDI-DI, that is:
- The primary identifier of a device.
- The main record of a device in the central database Eudamed.
- Referenced in certificates, declaration of conformity, technical documentation and the summary of its safety and clinical performance.
- A way of connecting devices with the same intended purpose, risk class and essential design and manufacturing characteristics.
- A key that connects all information related to a device.
The timeline
Medical device companies have a specific timeframe in which to achieve their compliance under the new EU MDR (by the 26 May 2020) and the new IVDR (by the 26 May 2022). Pivotal to this compliance will be receiving the UDI for every medical device in a company’s portfolio.
The compliance timeline for the UDI classification:
Class III implantable devices: 26 May 2021
Class IIa & IIb devices: 26 May 2023
Class I devices: 26 May 2025
The requirements
A universal identification system for medical devices requires a global labelling standard. This standard has been based on guidance from the International Medical Device Regulators Forum (IMDRF) and is laid out in the new EU MDR requirements—reflecting the current global effort to unify regulations across borders in order to improve patient safety and market transparency.
The specific MDR requirements for the UDI are as follows:
- The UDI is assigned to a device or its packaging, with higher levels of packaging assigned its own UDI (shipping containers are exempted).
- The UDI contains two parts: a UDI-DI and a UDI-PI (the UDI-DI will be unique at each level of device packaging).
- A new UDI-DI is applied when there is a change that could lead to misidentification of the device or any ambiguity over its traceability. This could be a change to a data element for the UDI in the centralized database, Eudamed, such as a change to its name or trade name, the device version or model, its label as single use, packaged sterile or need for sterilization before use, the quantity of devices provided in a package or critical warnings or contraindications: e.g. contains latex or DEHP.
- Manufacturers that repackage or relabel devices with their own label must retain a record of the original device manufacturer’s UDI.
- The UDI carrier for single-use devices of classes I and IIa that are packaged and labelled individually does not need to appear on the packaging but should appear on a higher level of packaging.
- For devices exclusively intended for retail point of sale, the UDI-PIs in AIDC (Automated Identification and data capture) are not required to appear on the point of sale packaging.
- If the manufacturer is using RFID technology, then a linear or 2D barcode (in line with the IMDRF standard) should also be provided on the label.
- Devices that are reusable should have the UDI carrier on the device itself. The UDI should be permanent and readable for use throughout the intended lifetime of the device. This requirement would not apply to a device if (a) this marking would interfere with the safety or performance of the device, or (b) the device cannot be directly marked because it is not technologically feasible.
MDR requirements for the UDI are also defined by the type of device:
- Implantable devices.
- Reusable devices requiring cleaning, disinfection, sterilization or refurbishing between uses.
- Systems and procedure packs.
- Configurable devices.
- Device Software.
Implantable devices:
- Implantable devices in the lowest level of packaging (‘unit packs’) will be identified or marked with an AIDC and UDI (UDI-DI + UDI-PI).
Reusable devices requiring cleaning, disinfection, sterilisation or refurbishing between uses:
- The UDI mark will be on the device and be readable after each procedure before it is ready for the next use.
Systems and procedure packs:
The contents of a system or procedure pack will have the UDI carrier on the packaging or on its devices.
- As a general rule, the UDI carrier for the system or procedure pack will appear on the outside packaging.
- The UDI carrier will be readable or scannable (as in the case of AIDC) whether it is on the outside packaging or inside transparent packaging.
Configurable devices:
- The UDI will be assigned to a ‘configurable device’ in its entirety and will be called the configurable device UDI. Each component of the configurable device that is considered a device by itself and is commercially available on its own will be assigned a separate UDI.
Device Software:
- The UDI will be assigned at the system level of the software. Only software which is commercially available on its own and software which constitutes a device in itself shall be subject to that requirement.
- A new UDI-DI will be required when there is a modification change to (a) the original performance, (b) the safety or the intended use of the software or (c) interpretation of data.
- Minor software revisions will require a new UDI-PI but not a new UDI-DI.
- When the software is delivered on a physical medium, e.g. CD or DVD, each packaging level will have a readable and scannable AIDC representation of the complete UDI.
- Only the readable portion of the UDI is required in electronic displays of the software.
The Tao of Excellence can assist organizations in understanding the subtle nuances of the UDI requirements. Contact us for guidance and expertise on the best ways to manage your device portfolio and the UDI timeline, and create efficient and cost-effective solutions that will meet the MDR requirements and achieve a timely compliance process for your company.
Deepa Rajagopalan
Phone
+41 52 685 51 65
Email
[email protected]
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