A Unique Device Identification system or UDI aims to provide a global identification system for medical devices. It requires manufacturers of medical devices to affix a unique alphanumeric or numeric code on the labels of medical devices. The UDI system aims to globally regulate the effective and safe use of medical devices. The United States Food & Drugs Administration (FDA) first brought the UDI guidelines in 2013 and is now a pre-requisite for medical devices manufactured in the United States. Other countries soon followed suit. The FDA, the International Medical Device Regulator Forum (IMDRF) and the European Commission, which is the European Union’s regulatory authority for medical devices, have been looking to create a globally applicable UDI system to efficiently identify medical devices. Scroll down to check more about UDI System for Medical Devices.
Benefits of UDI System for Medical Devices
The UDI system for medical devices aims to benefit many stakeholders like, inter alia, individual consumers, manufacturers of medical devices, hospitals and other similar institutions, healthcare providers and authorized healthcare authorities by:
- Helping identify counterfeit products being used in the healthcare sector
- Reducing clinical errors through documenting expiration dates of healthcare products consistently.
- Speedy access to information and quicker visibility into existing inventory.
- Quicker discovery of flaws in medical device information by requisite authorities
- Ensuring that information pertaining to implanted devices is retraceable and retained safely.
Depending on the country, the UDI system has two major components to it, namely, labelling and registration on the country-specific database. The UDI for medical devices is issued by GS1 in countries like, inter alia, the USA, China, EU, Saudi Arabia, and South Korea based on many regulations in these countries. Manufacturers looking to supply medical devices in these markets can do so by adhering to the standards set out by GS1 to fulfil the requirements of UDI.
Labelling Requirements of the UDI System for Medical Devices
The UDI for medical devices is an alphanumeric or numeric barcode which is readable by both machines and humans. The UDI is affixed either on the packaging of the device or on the device itself and can be used to access all information about the medical device. It is used in two forms, namely, 2D code or data matrix and 1D code or linear bar code. UDI System for Medical Devices has two major components:
- UDI Device Identifier or UDI-DI
The UDI device identifier links the manufacturer of the medical device to the device itself and is associated with the specific model of the medical device. It is the static portion of the UDI and is also referred to as the Global Trade Identification Number or GSIT. UDI-DI is assigned before deploying a product in the market and can be used to primarily identify characteristics of medical devices in databases of a particular country. Different packaging levels of one medical device can have different UDI-DI. The UDI-DI primarily consists of the manufacturer’s product code, the prefixes of the company and the check character.
- UDI Production Identifier or UDI-PI
UDI production identifier is assigned by the manufacturer and refers to the product information of the device and, for tissue, human cell, tissue-based or cellular products, a unique identification code. With the exception of the EU database, the UDI-PI values do not show in specific country databases. It is the dynamic or variable part of the UDI and identifies:
- Serial number
- Manufacturing date
- Medical device manufacturer’s batch number or lot number
- Expiration date
- Any other characteristics as per country-specific regulations
Requirements for UDI System for Medical Devices in India
As per Rule 46 of the Medical Device Rules, 2017, the fresh UDI Regulations, which will largely harmonize with the International Medical Device Regulator Forum’s UDI regulations, were to be adhered to by manufacturers of medical devices supplying their products in the Indian market. Rule 46, as it stood prior to 31 December 2021, mandated that “a medical device approved for manufacture for sale or distribution/import, shall bear a unique device identification which shall contain device identifier & production identifier” by 1 January 2022. However, the Ministry of Health & Family Welfare issued a notification on 31 December 2021 and amended Rule 46 of the Medical Device Rules, 2017. This amendment had the effect of delaying the implementation of the UDI regulations in India and has also forego the implementation of production identifier as it only mentions affixing of “unique device identification”. The new UDI regulations are expected to largely conform with the labelling requirements for the UDI system followed in other countries since the intent is to create a globally harmonious system to identify and regulate the usage of medical devices on an international scale.
The UDI system for medical devices aims to ensure patient safety and tackle adverse issues by source identification of a medical device through use and distribution. Many countries like the United States of America have already implemented UDI regulations for medical devices, and many countries like, inter alia, India, Australia, Canada, Brazil, China, and Singapore are looking to implement country-specific regulations which harmonize with the global UDI standards. Manufacturers looking to deploy medical devices in the Indian market must keep abreast with the developments in the UDI regulations in the country. With a comprehensive UDI system conforming to global UDI standards in place, it will become easier to identify and reduce medical errors, ensure patient safety, and have speedy access to accurate device information.