The new European Union Medical Device Regulations (EU MDR) 2017/745 and In-vitro Diagnostic Medical Device Regulation (EU IVDR) 2017/746 are landmark legislations designed to enhance the safety and traceability of medical devices and in-vitro diagnostics within the EU. One of the central elements of these regulations is the Unique Device Identification (UDI) system for device identification. The primary regulations governing the establishment of the UDI system can be found in Chapter III and Annex VI of the two medical device Regulations.
Significance of UDI under EU MDR and IVDR
The implementation of the UDI system under EU MDR and IVDR offers several critical benefits:
Enhanced Patient Safety: UDI ensures that each device is uniquely identifiable, reducing the risk of confusion between similar devices. This enhances patient safety by minimizing the chances of incorrect device usage.
Improved Traceability: In the event of a device recall or safety concern, UDI allows for rapid and precise identification of affected devices. This enables manufacturers and regulators to take swift action to protect patients.
Streamlined Market Surveillance: Regulatory authorities can use the UDI system to monitor devices more effectively, ensuring they comply with safety and performance standards during their lifecycle.
Facilitated Post-Market Surveillance: UDI data helps manufacturers and regulators detect potential issues or adverse events associated with devices in real-time. This aids in improving the overall safety and quality of medical devices and diagnostics.
UDI is a system that assigns a unique alphanumeric code to each medical device, making it easily identifiable and traceable throughout its entire lifecycle. The UDI system is pivotal in enhancing patient safety, streamlining device recalls, and enabling effective post-market surveillance. Under EU MDR and IVDR, UDI is a mandatory requirement for all medical devices and in-vitro diagnostic devices, and it consists of three key components:
Basic UDI-DI: Any Basic UDI-DI shall identify the devices (group) covered by that Basic UDI-DI in a unique manner. The Basic UDI-DI is an identification code that pertains to a group of products rather than a single, specific product. One Basic UDI- DI is for devices within the same category with same Intended purpose, Risk class, Essential design and Manufacturing characteristic
UDI-DI (Device Identifier): This part of the UDI represents the specific device model and variant. It includes information about the manufacturer, device version, and other key details that help distinguish one device from another.
UDI-PI (Production Identifier): UDI-PI (Unique Device Identifier-Production Identifier) contains manufacturing batch or serial number, expiration date, software ID, and manufacturing date. Manufacturer defines UDI-PI details, vital for traceability and post-market monitoring. If the label shows lot/serial number, software ID, or expiry date, they're part of UDI-PI. If only manufacturing date's on the label, it's used as UDI-PI. For active implantable devices, UDI-PI includes serial number; for other implantable devices, serial or lot number. Each configurable device has a specific UDI-PI. Notably, UDI-PI info can't be in the UDI database.
Device Specific UDI Requirements
System and Procedure Packs: These must have a Basic UDI-DI assigned and registered in the EUDAMED database before market placement, as per Article 29(2) of MDR.
Devices under EU MDD and AIMDD: Legacy devices under the old directives (EU MDD and AIMDD) can be placed on the market with valid Directive certificates, exempt from UDI requirements but must be registered in EUDAMED.
Software Devices: Software devices should have UDI assigned at the system level. Only standalone software or software functioning as a device needs UDI, with software identification serving as the control mechanism.
Reusable Devices: Reusable devices need a permanent, readable UDI carrier, unless direct marking interferes with safety or isn't technologically feasible.
Single-Use Reprocessed Devices: Those reprocessing single-use devices assign a new Basic UDI-DI and UDI. The original UDI should be recorded in technical documentation and quality management systems for traceability, except when reprocessed in a health institution, with different obligations applying as per MDR Art. 17(3).
UDI Issuing Agencies
The entities responsible for issuing UDIs manage a system for their assignment. The following entities are designated by European Commission to issue an UDI -
Health Industry Business Communications Council (HIBCC)
International Council for Commonality in Blood Banking Automation (ICCBBA)
Informationsstelle für Arzneispezialitäten (IFA) GmbH
According to medical device regulations, manufacturers are responsible for UDI assignment, UDI carrier placement, updating device information in the Eudamed database and placing the UDI carrier on the device label or packaging. Updates must be made within 30 days of any relevant changes.
Manufacturers must maintain up-to-date lists of all UDIs assigned to their devices as part of their technical documentation. This documentation must be accessible to EU Competent Authorities for at least 10 years, or 15 years for implantable devices, following the market entry of the last device covered by a manufacturer's declaration of conformity.
Distributors and importers must verify UDI assignment where applicable. Importers and distributors involved in translating or repackaging devices must ensure that these activities donot affect the readability of the UDI carrier and that they are integrated into their quality management systems. Distributors, importers, and other entities taking on the manufacturer's responsibilities also assume UDI-related responsibilities, including labeling.
UDI and Device Labeling
The UDI must be on the label or the device itself and on all higher levels of packaging, with each level having its unique UDI. Shipping containers are exempt. The UDI must be in both plain-text (human readable) and Automated Identification for Data Capture (AIDC) formats. If space is limited, AIDC alone is acceptable, except for devices intended for home use where HRI is required.
For single-use devices of certain classes, the UDI can be on a higher level of packaging but should be on individual packaging when healthcare providers don't access higher levels. Retail devices don't need UDI on point-of-sale packaging if it's readable through the device's packaging. More details in Annex VI Part C of the regulations.
When is a New UDI or Changes of UDI-DI Needed
A new UDI-DI is necessary whenever there are changes that could cause device misidentification or traceability issues. This includes changes in name, device version, labeling as single-use, sterile packaging, sterilization requirements, quantity per package, critical warnings, and CMR/Endocrine disruptors. Each UDI-DI must correspond to a single Basic UDI-DI.
Exceptions from UDI Requirements
The UDI system should apply to all devices, except custom-made and performance study/investigational devices. Devices for special purposes under Article 21(3) MDR or Article 19(3) IVDR, and those used for trade fairs or demonstrations, are exempt from UDI requirements. However, such devices must visibly indicate their intended use for presentation or demonstration and cannot be used until they comply with regulations.
While the UDI system offers numerous advantages, its implementation poses challenges for manufacturers:
Data Management: Manufacturers must establish robust data management systems to assign, manage, and update UDI information for each device.
Global Harmonization: Manufacturers often face the challenge of complying with multiple UDI systems worldwide, as different regions may have their own UDI requirements.
Costs and Resources: Implementing the UDI system requires investment in technology, staff training, and data management infrastructure.
Impact on the Medical Device Industry
The UDI system under EU MDR and IVDR has a significant impact on the medical device industry:
Regulatory Compliance: Manufacturers must ensure compliance with UDI requirements to market their products in the EU. Non-compliance can result in market access issues.
Competitive Advantage: Companies that effectively implement UDI can use it as a competitive advantage, demonstrating their commitment to patient safety and regulatory compliance.
Improved Device Lifecycle Management: The UDI system facilitates better device lifecycle management, allowing manufacturers to monitor and improve device performance continually.
The Unique Device Identification (UDI) system under EU MDR and IVDR is a game- changer for the medical device industry in Europe. It not only enhances patient safety and traceability but also streamlines regulatory oversight and post-market surveillance. While the implementation may present challenges, the long-term benefits in terms of patient safety and regulatory compliance make it a crucial component of the evolving landscape of medical device regulation in the European Union. Manufacturers and stakeholders should prioritize UDI compliance to succeed in this highly regulated industry.
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