The Medical Device Coordination Group (MDCG), an advisory body of the European Commission composed of representatives of all the EU Member States, issued guidance dedicated to the Unique Device Identification (UDI) system implemented by the Medical Device Regulation 2017/745 (MDR) and In Vitro Diagnostic Device Regulation 2017/746 (IVDR).
UDI: Brief Overview
One of the highest-ranked priority spheres in today’s improvement of medical device regulations is the implementation of the Unique Device Identification system, which is expected to improve the safety of patients and the effectiveness of all business processes within the industry in general. The system is based on generally accepted standards to be implemented at all steps of the supply chain. The countries implementing the UDI system engage the GS1 and HIBCC (Health Industry Business Communications Council) agencies accredited by the FDA.
The core elements of the UDI system are the following:
- UDI-DI – device identifier (or GTIN/LIC in GS1 and HIBCC systems respectively), a static element containing information regarding the particular model or version of a medical device and about its manufacturer,
- UDI-PI – manufacturing identifier, a variable element containing the lot number, serial number, shelf life and/or expiration date, and manufacturing date.
Actually, each UDI includes both UDI-DI and UDI-PI to provide the whole scope of information necessary to operate the data and information associated with the device, stored in the international database.
The Unique Device Identifier should be assigned to the medical device and/or its packaging. Each packaging level shall have its own UDI. At the same time, packaging for transportation (containers or protective packaging for individually packaged devices should not have UDIs. In case if the device has not the appropriate UDI itself, basic-level UDI should be assigned to the packaging containing a certain quantity of such individual devices. Each component or accessory which constitutes a medical device intended to be marketed separately shall have a separate UDI except the situations when they are the parts to the set of devices (system) assigned with its UDI.
The manufacturer must duly notify the authority about any changes to the way the UDI-DI is placed on the packaging, while such changes do not require prior authorization. Depending on the particular situation, the UDI could be placed as a linear barcode, 2D/Matrix QR-code or RFID code. When choosing the particular approach to use, the manufacturer shall ensure that there is enough spare space on the labeling and also that all parties involved in the supply chain would be able to read the code in the appropriate format.
It is expected that the implementation of the UDI system will allow tracking medical devices on each step of the supply chain with the improved accuracy, allowing to figure out adverse events and incidents associated with the devices. It would be also useful in case of withdrawal of the devices. In general, the system is intended to improve:
- Tracking the device during its whole lifecycle,
- Safety monitoring,
- Post-marketing surveillance (adverse event notifications and withdrawals),
- Collection of documents for the purpose of long-term performance monitoring and analysis.
The whole process could be divided into three consecutive steps: assigning the Unique Device Identifier to the particular device, placing the UDI on the packaging and submission of the information to the database.
The information to be submitted to the public database includes:
- Trade/brand name,
- Model and version,
- Quantity in a package,
- Levels of packages,
- Sterility requirements and methods,
- Placement of the UDI on the device,
- Compatibility details,
- Specific requirements,
- Reference to the approval issued by the appropriate national regulating authority,
- Product code,
- Class of the device,
- Manufacturer information.
UDI System: Key Points
As it was already mentioned above, the UDI system has been introduced within the new medical device regulatory framework based on the MDR and IVDR replacing the appropriate Directives.
The present guidance on the UDI and changes to the UDI constitutes an updated version of the guidance document issued by the MDCG earlier in 2018.
The Basic UDI-DI is the core element used to simplify any operations with the data. It allows storing the information added to the database in a structured way, ensuring the internal connections among all documents, including declarations, certificates and technical files depending on the particular group of the devices based on the intended purpose indicated by the manufacturer, class of the device in accordance with the risk-based classification, and also the design and characteristics.
It is important to mention that UDI-DI should be removed from any trade packaging or labeling available to the end-users. Thus, basic UDI-IDs are used to identify a group of devices.
According to the requirements set forth by the new Regulations, the information contained in the certificates (e.g. technical documentation assessment certificates, type-examination certificates, and product verification certificates) should be sufficient to identify the device. In particular, the information included in the aforementioned documents shall cover:
- The name of the device,
- The model of the device and its type,
- The intended purpose as indicated by the manufacturer in the materials supplied with the device (e.g. instructions for use),
- The class of the device in accordance with the risk-based classification.
The certificate shall cover all the devices within the same Basic UDI-ID.
The Regulations also provide the scope of information to be included in the declaration of conformity, namely:
- The Basic UDI-DI,
- The product and trade name,
- The product code,
- The catalog number or similar element used for making references.
Changes to the UDI-DI
Under certain conditions, a new UDI-DI should be assigned. For example, it would be needed in case if the changes made could result in the inaccurate identification or impact traceability of the devices. The list of changes requiring the assignment of the new UDI-DI includes the changes to:
- The name of the device or product name,
- The version of the device or its model,
- “Single-use” label for the devices that could be used only once,
- Sterile package,
- Indication on necessary sterilization before using the devices,
- The quantity of the devices supplied in a single package,
- Important warnings.
When assessing the necessity of changing the UDI-DI, some key aspects should be taken into consideration:
- Direct marking of the device,
- Approaches utilized to control the manufacturing process, such as manufacturing or expiration dates, lot number, the serial number of the device, software identification. Changes to these elements would not require the assignment of an entirely new UDI-DI since they are not reflected on the label of the device.
It is also important to mention that reprocessed devices, software, and procedure packs fall outside of the scope of the present guidance, and the device-specific requirements for the aforementioned devices are highlighted in other documents issued by the MDCG.
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