The International Medical Device Regulators Forum (IMDRF) published several guidance documents on the Unique Device Identification (UDI) system, starting from 2013 (IMDRF/UDI WG/N7, “UDI Guidance”), because IMDRF regulators commonly agreed that harmonised global identification principles and system were necessary to unambiguously identify medical devices in the global healthcare supply chain. In the intention of the regulators, the benefits should be more likely achieved when the UDI is recorded in real world electronic health systems (e.g., electronic health records, device registries, material management systems, and reimbursement data) and used as part of the real world evidence to improve clinical and regulatory decision making.

The U.S.A. has been the first country that published the UDI rule (21 CFR Parts 16, 801, 803, et al., September 2013) and implemented the UDI system with the aim of adequately identify devices through distribution and use: the last stage of implementation related to Class I devices has been postponed due to the Covid-19 pandemic impact on the supply chain readiness. The European Commission, on the other side of the Ocean, adopted the new Medical Device Regulation (so called MDR, Regulation (EU) 2017/745) on 26 May of 2021, but some aspects related to the UDI system implementation are still under definition and the European database (Eudamed) module related to the UDI data has been recently rolled out, with some bugs still to be fixed. The Chinese National Product Administration (NMPA) published on August 2019 the Order no. 66 to establish the UDI rule and is trying to perform a staggered implementation, facing some issues related to the UDI database functionalities, that delayed the planned roll-out.

Many countries are planning the implementation of the UDI system, while others have already published and are implementing the related regulations with a staggered approach: Australian TGA completed the consultation pathway and is managing several consultations with the stakeholders to define the UDI rule; Brazilian ANVISA completed the public consultation on the proposal in September 2021 and publish the UDI resolution in December 2021; Canadian Health Ministry completed the public consultation at the end of September and is evaluating the outcome. Saudi Arabic Ministry of Health, Ecuadorian ARCSA, Taiwanese Ministry of Health and many other Health Authorities published UDI regulations and planned the staggered implementation of the UDI system and related databases.

Comparing the UDI rules and databases of U.S. FDA, European Commission, Chinese NMPA it is clear that there are some differences, for example related to the UDI structure (MDR introduced the Basic UDI-DI, that is unique worldwide), the new UDI-DI triggers, the direct marking requirements, the database structure and the UDI data required to be submitted for the device registration in local databases. If we consider that many other countries are adopting their own rules with different timelines, and the implementation of the UDI system is connected with the local supply chain structure and technology (bar code readers vs data matrix readers), the complexity of the global commerce of medical devices is increasing dramatically.

The main part of the UDI rules refers to International Standards Organization documents, as ISO IEC 646:1991 “7-bitcoded character set for information interchange”, ISO IEC 15459-2:2006 “Information technology - Unique Identifiers – Part 2: registration procedures”, ISO IEC 15459-4:2008 “Information technology - AIDC - Unique Identification – Part 4: individual products and product packages”, ISO IEC 15459-6:2014 “Information technology - AIDC – Unique Identification – Part 6: groupings”, but the technological progress on the traceability solutions is not captured by the UDI rules, regulations and standards in a timely manner.

In addition to the above considerations, the UDI system is not only a labelling and submission requirement, but it involves the post-market surveillance activities and the communication with local Health Authorities, requiring the participation of device development, regulatory affairs, quality assurance, IT and operations / manufacturing departments to collect and maintain regulatory data, ERP product data, labelling data: each function of an organization has a role in the UDI system. A solution could be to adopt a life cycle management software for UDI codes and data collection, management and communication Machine-to-Machine (M2M) to local Health Authorities databases, but this would require a big effort for the implementation, validation and maintenance: it makes sense when the number of devices to be managed is very high (some thousands).

In this global complex regulatory framework, to be in compliance with MDR UDI provisions, contact us to guide you into the UDI system implementation road.

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