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Unique Device Identification (UDI) - GMTA Global Medical ...

1 Unique Device Identification (UDI): Insights and Benefits from a Single UDI System in the International Arena White Paper January 2018 2 EXECUTIVE SUMMARY The implementation of a globally harmonized Unique Device Identification (UDI) system will positively impact many aspects of the Medical Device and healthcare ecosystem by increasing patient safety and optimizing patient care. There are, however, considerations that must be examined and addressed prior to the development of localized UDI requirements in a given market.

harmonized unique device identification (UDI) system will positively impact many ... databases, such as the FDA’s Global Unique Device Identification Database (GUDID) ... Global Medical Device Nomenclature (GMDN): The GMDN is a system of internationally agreed terms used to identify medical devices. The GMDN database

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Transcription of Unique Device Identification (UDI) - GMTA Global Medical ...

1 1 Unique Device Identification (UDI): Insights and Benefits from a Single UDI System in the International Arena White Paper January 2018 2 EXECUTIVE SUMMARY The implementation of a globally harmonized Unique Device Identification (UDI) system will positively impact many aspects of the Medical Device and healthcare ecosystem by increasing patient safety and optimizing patient care. There are, however, considerations that must be examined and addressed prior to the development of localized UDI requirements in a given market.

2 These considerations include labeling requirements, implementation timelines, the treatment of products already in commerce, and the assembly and maintenance of a UDI database. The United States Food and Drug Administration (FDA) was the first government agency to issue and implement UDI requirements. Manufacturers and the public provided input throughout the UDI rulemaking process and FDA sought input from a broad set of stakeholders, including the public, manufacturers, and other government health agencies.

3 FDA based its rule on a number of international standards and external consultations, consistent with the International Medical Device Regulators Forum (IMDRF).1 As a result of significant thought and consideration, the FDA s final UDI rule achieves a balance of the regulator s needs and industry s capabilities without compromising patient and user safety. This 1 See IMDRF, UDI Guidance, Final Document (Dec. 9, 2013), available at has led to a successful set of rules and policies.

4 A globally harmonized approach to UDI is critical to realizing the benefits of such a system, is a prerequisite for Medical Device traceability in a globalized economy, and lays the groundwork for the worldwide exchange of Medical Device data. In contrast, the creation of multiple UDI regimes will stifle innovation in the Medical Device industry, create product shortages, and cause confusion in the supply chain. For example, different criteria regarding events that trigger a new UDI for an existing product could lead to unintended outcomes and incompatible data, including significant changes to product labels, database entries, or additional product registrations, which would ultimately slow down time to market for product changes and impact patient access.

5 In addition, variations among regions or countries would add significant effort and costs for Device manufacturers, down-stream customers, health systems, and patients without any added benefit to patient safety. Creating a globally harmonized UDI system is achievable when countries adopt similar UDI requirements. In this regard, a country seeking to implement new UDI rules should rely on the IMDRF UDI Guidance,2 along 2 See IMDRF, UDI Guidance, Final Document, p. 3 ( The UDI System is intended to provide a single, globally harmonized system for positive Identification of Medical devices .)

6 Healthcare professionals will no longer have to access multiple, 3 with reference to FDA s final UDI rule as a model for constructing rules of their own. Below, we identify: (1) The important aspects of the FDA s final UDI rule that should be adopted globally; and (2) information learned while implementing the rule. This information is intended to assist the formulation of new UDI rules in a harmonized manner, which in turn will make compliance more achievable with more efficient use of resources for regulators and the Medical Device and healthcare ecosystem, ultimately enhancing patient safety.

7 As discussed more fully in this document, our recommendations are as follows: 1. UDI rules should be adopted in a globally harmonized manner. 2. UDI rules should offer a phased in approach with implementation based on product risk classification. The implementation period should begin no less than two years from issuance of the regulation and when the UDI database is available. 3. UDI rules and policies should rely on international standards and globally accredited UDI issuing agencies, in addition to the IMDRF UDI Guidance, and consider the evolution of UDI technology.

8 4. Manufacturers should be permitted to submit information to databases using inconsistent, and incomplete sources in an attempt to identify a Medical Device and, its key attributes. ), standards-based submission options to account for their variation in size and capabilities, such as the use of web interfaces or HL7 formats. Globally standardized core data elements should become the common denominator for any national implementation.

9 5. Regulators should provide assistance when implementing a new UDI system, such as setting up a help desk, providing training opportunities, and issuing guidance documents. 6. UDI rules should provide the regulator with an efficient and expedient mechanism to grant exceptions, exemptions, alternatives and extensions that may exist for specific product areas or for specific manufacturers. 7. UDI rules should exempt all devices manufactured or labeled prior to the UDI rule effective date, including those that are held on a consignment basis.

10 8. Regulators should understand the implementation variations that occur between manufacturers with respect to use of Device identifiers and maintain flexibility to account for a manufacturer s specific needs by staying within the established framework of the globally accredited UDI issuing agencies. 4 9. Regulators should drive Global convergence for the use of new product identifiers. 10. Implementation timelines related to UDI database changes must account for industry s needs to update internal systems and processes.


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