Unique Device Identification (UDI) is a directive of the FDA, the US federal agency to monitor food and drug administration, for the implementation of clear labeling for medical devices. This policy aims to increase transparency in the supply chain, improve patient safety and simplify product recalls.
The FDA introduced the UDI uniform labeling system for medical devices on September 24, 2013. For all medical device manufacturers who want to continue to export their products to the US market, this means that all products that fall under the definition of medical devices of IMDRF (International Medical Device Regulators Forum), must have introduced the UDI system before the deadline. In addition to the current UDI requirements in the US (and Turkey), more binding rules for the EU and Asia are in the making. In Europe, a “system of unique product numbers” will be introduced, bringing into effect the new European legislation for medical devices.
The FDA’s UDI System
Since 2013, the “FDA final rule” has required manufacturers of medical and In-Vitro Diagnostic Products (IVD) to provide their products with a globally unique identification number with defined manufacturing and production information. These markings must be applied in plain text as well as in a machine readable form, at all relevant levels of packaging a product, e.g. in the form of barcodes or 2D codes.
Uniqueness is achieved in that the batch/lot no., serial number or the expiration date of the product are a part of the UDI. In addition, the manufacturer must define product-specific master data records in a central government database (GUDID). You can access this information using the unique identification number. Since September 2014, the rules already apply to most strictly controlled Class III medical devices (e.g. implants, HIV tests, …). These rules will be extended to other classes of medical devices by 2018.
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1. Unique Device Identifier (UDI)
The Unique Device Identifier is a unique numeric or alphanumeric code, consisting of a device ID (DI = Device Identifier – e.g. GTIN), a fixed, ISO-based code for the Product ID and the production ID (PI = Production Identifier), which contains variable current product data, such as batch/lot number, serial number and/or the expiration date).
2. The UDI disk (Carrier)
The UDI code must be on the product and / or packaging in plain text (HRI = human readable interpretation) and machine readable (AIDC = automatic identification and data capture), e.g. applied as a barcode.
3. The UDI database (GUDID)
The UDI is the key to the FDA’s UDI Global Database (GUDID). It is a freely accessible database from the FDA which includes all medical devices sold in the United States. The products must be registered by the manufacturer in this database including the defining product characteristics.
The GUDID contains ONLY the Device Identifier (DI), which serves as the primary key to query other device information from the database. Production Identifiers (PIs) are not transmitted to or stored in the GUDID, but the GUDID contains PI criteria that indicate which PI attributes are shown on the device label.
The deadlines for the implementation of the UDI depend on a product’s risk category. Medical devices with the highest risk category, i.e. Class III products (e.g. pacemakers, breast implants), already had to be UDI-compliant within one year of the FDA’s decision. As of September 24, 2014, no Class III products may therefore be sold in the United States without UDI-compliant labeling.
For medical devices of medium risk (Class II) this time period is two to three years and for products in the lowest risk class (Class I), five years. If the policy comes into effect for Europe, it means that all medical device manufacturers will have to label their products UDI compliant within the next few years.
Upcoming deadlines for implementation:
September 24, 2015
Class II Medical Products (implantable, life-supporting, and life-sustaining devices) must carry labels and packaging with the UDI code. With reusable products, the code on the product itself must be “permanently” applied. Stand-alone software that belongs to this class of products must also be identified. Product data defined with an asterisk must be sent to the FDA’s GUDID (Global UDI Database).
September 24, 2016
Labels and packaging for Class II products must bear the UDI code. With reusable products, the code on the product itself must be “permanently” applied. Stand-alone software that belongs to this class of products must also be identified. With reusable products from Class III, the code on the product itself must be “permanently” applied. Product data defined with an asterisk must be sent to the FDA’s GUDID.
September 24, 2018
Labels and packaging of medical devices which are not in Class I, Class II or Class III, must bear the UDI code. With reusable products, the code on the product itself must be “permanently” applied. Stand-alone software that belongs to Class I must also be identified. With reusable products from Class II, the code on the product itself must be “permanently” applied. Product data defined with an asterisk must be sent to the FDA’s GUDID.
There are some exceptions to the data and classes mentioned above; for more info and the exact wording, see the links to the FDA website.
Webinars on the FDA’s “UDI”
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