Identification of drugs and medical devices
Counterfeit medicines are a global threat and a growing number of countries, including Argentina, Brazil, India, South Korea, Saudi Arabia, Turkey and the European Union as a region, have adopted or are in the process of adopting requirements to use global, unique drug identifiers and serialization to secure the supply chain.
Since February 9, 2019, a drug traceability system established by Delegated Regulation (EU) 2016/161 of the European Commission of October 2, 2015 to supplement Directive 2001/83/EC on counterfeit drugs has been successfully operating in the European Union.
The main objective of the European Directive is to prevent counterfeit medicines from entering the legal supply chain and to ensure the integrity and authenticity of medicinal products (safety indicators and serialization).
Detailed rules have been established for the safety indicators on the packaging of medicines for human use. One of the indicators is the mandatory printing of the GS1 GTIN – Global Trade Unit Number – in a 2D Data Matrix barcode.
What does a barcode include?
The packaging of medicines and media products contain a GS1 barcode – linear or 2D DataMatrix barcode. It encodes basic information about the product, such as the lot number, serial number, date of manufacture or expiration date. For medical devices, this data is known as a production identifier (PI). According to the GS1 standard, Application Identifiers (AI) are used to integrate PI data into the code.
When scanned, this information is read by the scanning device, then shared into a resource management and planning (ERP) system or directly into the patient’s electronic record.
Marking of medical devices
Patient safety has been identified as a strategic priority by the European Commission, the US Food and Drug Administration (FDA) and other regulatory bodies. In this regard, regulations have been developed with a focus on medical devices and in vitro diagnostic devices (IVDs), which aim to introduce a globally harmonized and consistent approach while following the IMDRF guidelines.
The Medical Devices Regulation EU MDR 2017/745 and the In Vitro Diagnostic Devices Regulation (in vitro EU IVDR 2017/746) introduce legal requirements for the implementation of a system for the unique identification of medical devices (UDI, Unique Device Identifier) in Europe. The UDI components are UDI-DI (static component), UDI-PI (manufacturing data) and Basic UDI DI (medical device group). GS1 has been designated as the UDI issuing agency.
According to the requirements, the UDI must be present on the label of the unpackaged products; the packaging, when available, and in some cases directly on the product itself.
A European database EUDAMED (European Databank on Medical Devices) has been built, in which manufacturers must enter data on medical devices. When entering, it is necessary to indicate the basic identifier Basic UDI-DI of the group of medical devices to which the corresponding device belongs. In the GS1 standards, the correspondence of Basic UDI-DI is called Global Model Number (GMN/Global Model Number).
Deadlines for registration in EUDAMED
Steps required for manufacturers:
All packaging of medical devices and in vitro diagnostic devices must be identified with a UDI. When required, the identification must be placed directly on the medical device. Manufacturers using GS1 GTIN numbers for their products have the necessary basic requisites to create a UDI.
The UDI is placed on all levels of medical device packaging, in human-readable (text) format and encoded in an easy-to-scan barcode at the points where information about the marked device needs to be processed.
The global model number (GMN) of the product and/or product family must be determined.
To access EUDAMED, a Single Registration Number (SRN) must be requested and obtained. The next step is to register local LUA administrators (Local user administrators) of the company. These are the persons who are authorized to act on behalf of the manufacturer.
Benefits of drug and medical device identification
Risks and harm to the patient from counterfeit products or articles entering the supply chain are prevented
Traceability is improved and when a violation or presence of a harmful substance is found, products can be recalled more quickly
Improved monitoring of marketed drugs and medical devices to summarize patient outcomes and monitor for adverse reactions.
Patient-Level Information and Costing Systems (PLIC)
Ability to track medications and products used in a certain procedure or time frame and more accurately calculate costs for the patient.
Eliminate manual inventory and track inventory in real time
The intake of medication, the use of medical devices or a specific manipulation can be reflected in real time in the patient’s file by scanning the barcode on the spot.
Identify your drugs and medical devices with a unique, standardized barcode