Joint MTAA, IVD Australia, ADIA and AusBiotech Policy Paper: UDI Implementation in Australia May 2018
Medical device regulators world-wide are adopting a unique device identification standard - the Unique Device Identification (UDI) - to improve identification and traceability for medical devices through their distribution and use. Medical device traceability is essential to ensure effective post-market safety-related activities in a globalized economy, such as incident reporting and targeted field safety corrective actions.
The UDI was initially introduced in September 2013 by the U.S. FDA and its implementation continues to be phased in . The UDI has also been adopted by the International Medical Device Regulators Forum (IMDRF) thus becoming an internationally recognised standard for unique medical device identification .
The UDI consists of a series of numeric or alphanumeric characters that is created through internationally accepted device identification and coding standards and that allows unambiguous identification of specific devices on the market. UDI on a device label or package is composed of two parts, defined in the IMDRF UDI Guidance as follows:
- Device Identifier (UDI-DI) – a unique numeric or alphanumeric code specific to a model of medical device and that is also used as the “access key” to information stored in a UDI database; examples of the UDI-DI include GS1 GTIN (Global Trade Item Number), HIBC, ISBT 128-PPIC (Processor Product Identification Code);
- Production Identifier (UDI-PI) – a numeric or alphanumeric code that identifies the unit of device production; UDI-PI include serial number, lot/batch number, Software as a Medical Device (SaMD) version and manufacturing and/or expiration date;
The new European Medical Device Regulations (EU MDR) and In Vitro Diagnostic Medical Devices Regulations (EU IVRD) adopted in 2017 include UDI provisions in Article 27 (MDR) and Article 24 (IVDR) Unique Device Identification system; Article 28 (MDR) and Article 25 (IVDR) UDI database; and Article 29 and Article 26 (IVDR) Registration of devices.
In Australia, the current most-commonly used approach to market authorisation remains acceptance of the approval issued by a European notified body . Over 90% of medical devices included in the Australian Register of Therapeutic Goods (ARTG) rely on CE marking certification issued in Europe. Therefore, it is imperative that Australian regulations remain closely aligned with the EU regulations and international best practice that enables the world-wide exchange of medical device data.
To read more, please download the report below.