ABOUT UDI MEDICAL DEVICE REGULATIONS

Identification standards make all the difference

Governments around the world have adopted regulations for the proper identification and subsequent traceability of medical devices to help identify counterfeit products, facilitate the recall process and create greater efficiencies.

One of the norms adopted in several countries is a system to identify medical devices through a unique identifier, commonly called Unique Device Identification (UDI). The carrier of this information can be a barcode, a Data Matrix (2D code) or RFID tag, for example.

The information required by law in those data carriers can vary according to the classification of medical devices in each country. For example, in the U.S., depending on the level of risk to the patient/user, medical devices are categorized in Class I, Class II and Class III. In the European Union, Class II includes subclasses A and B. In both cases the scale goes from devices with the least risk (I) to those with the most (III). In all three classes, the batch and product number is commonly required; however, a serialized UDI is mandatory only in specific devices belonging mostly to Class II and Class III.

UDI COMPONENTS

A UDI code consists of various identification components.

Whether they go by generic names as specified by the FDA or specific ones as standardized by GS1, the information is similar.

A UDI is a unique, alphanumeric code, composed of two parts:

  • The Device Identifier (DI) section is a 14-digit code representing the country of origin, the manufacturer and the product type. It is also the identifier used to access the Global UDI Database (GUDID). The GS1 Global Trade Item Number (GTIN) enables this aspect of the UDI.
  • The Production Identifier (PI) or Application Identifier section is a variable code that includes the device’s manufacturing and/or expiration date, the lot or batch number and the item serial number, when required.
Machine Vision - Description of a UDI barcode for serialization - Traceability

Learn more about UDI regulation and the benefits of UDI implementation for your business by watching our webinar Benefits of UDI and Tips on Optimizing Implementation.

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SOME EXAMPLES OF REGULATIONS

Because of the size and complexity of the medical device industry, regulations will be applied in different phases aligned with the device classification in each country. Here are some examples of the laws in place:

Machine Vision - Icon of a flag from USA

United States

In 2013, the U.S. Food and Drug Administration (FDA) released a final rule establishing a unique device identification (UDI) system designed to adequately mark and identify devices through the healthcare supply chain (distribution and use).

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Machine Vision - Icon of a flag from European Union

European Union

In April 2017 the European Commission adopted the EU Medical Device Regulation (MDR) and the In-vitro Diagnostic Regulation (IVDR). It also identified requirements for the EU UDI system.

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Machine Vision - Icon of a flag from Turkey

TURKEY

Medical devices in Turkey are manufactured and marketed in accordance with the EU regulations. The Turkish Medicine and Medical Devices Agency created the Turkish Medical Device Tracking System (MDTS) under the 2003-2013 Health Transformation Program.

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Machine Vision - Icon of a flag from Brazil

BRAZIL

In 2018, the Brazilian National Health Surveillance Agency (ANVISA) published Resolution RDC232, requiring all labels for coronary artery stents, pharmacological stents for coronary arteries, and implants for knee or hip arthroplasty to include traceability barcodes.

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