Unique Device Identification (UDI) for medical devices
Medical device traceability is essential to ensure effective post-market safety-related activities in a globalised economy, such as incident reporting and targeted field safety corrective actions. The UDI was initially introduced in September 2013 by the U.S. FDA with a staged implementation, starting with high-risk devices. The UDI has also been adopted by the European Union and the International Medical Device Regulators Forum (IMDRF) thus becoming an internationally recognised standard for unique medical device identification.
The development and implementation of the Unique Device Identification System (the UDI System) are widely acknowledged by the industry and regulators as an effective mean of ensuring timely access to complete, accurate and consistent information about medical devices. Demand is growing for improved traceability of medical devices in the supply chain. There is now worldwide recognition that, in the interests of patient safety and improved industry outcomes, the ability to unambiguously identify medical devices is essential.
An Australian UDI system should be implemented following fundamental principles:
- Adoption of a globally harmonised UDI system, in accordance with the IMDRF UDI guidance IMDRF/UDI WG/N7FINAL:2013;
- Adoption of rules and policies that align with international coding standards of UDI issuing agencies designated in the EU and accredited in the U.S. - Automatic Identification and Data Capture (AIDC) such as linear or matrix bar code, smart cards, biometrics and Radio Frequency Identification (RFID); and Human Readable Interpretation (HRI);
- Establishment of an Australian UDI database (AusUDID) owned and managed by the TGA; the best practice is for regulatory agencies to build their own UDID database. The AusUDID should allow sponsors to update information for their own products free of charge and should be accessed by the general public free of charge.
Currently, there are three issuing entities accredited/ designated by the U.S. FDA and the European Commission:
- Health Industry Business Communications Council (HIBCC)
- International Council for Commonality in Blood Banking Automation (ICCBBA)
In June 2019 a fourth issuing agency has been designated in the EU: Informationsstelle für Arzneispezialitäten - IFA GmbH.
Official accreditation/ designation of UDI issuing agencies ensures that the systems for the issuance of UDIs that are operated by designated/ accredited issuing agencies conform to certain international standards.
Industry’s position is that TGA should also accredit/ designate UDI issuing agencies locally. Australia should recognise and accept UDIs issued by all EU-designated/ U.S.-accredited UDI issuing agencies – HIBC, ISBT-PPIC and GS1 GTIN - without favouring or endorsing any single one in particular. This will enable a level playing field and ensure that the UDI systems that are implemented in Australia will not impede global trade of therapeutic goods.
More details are available in the Joint MTAA, IVD Australia, ADIA and AusBiotech Policy Paper: UDI implementation in Australia, May 2018 and the MTAA Submission to TGA Consultation: Proposal to introduce a Unique Device Identification system for medical devices in Australia, February 2019.
U.S. FDA Unique Device Identification - UDI
EU Commission Recommendation of 5 April 2013 on a common framework for a unique device identification system for medical devices in the Union
IMDRF UDI Guidance: http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-131209-udi-guidance-140901.pdf