Unique Device Identification Services in Pakistan(UDI)

UDI stands for Unique Device Identification. The unique device identification services is an identifier uniquely assigned to a device. The system allows for better tracking, inventory management, and reporting adverse events. It also helps companies to prevent fraud and abuse and helps to improve patient safety.

What is a Unique Device Identifier, or UDI System?

Medical devices that are meant to be reprocessed and reused must have Unique Device Identifier (UDI) systems. No matter how they are packaged or labelled, the devices are always traceable thanks to the UDI system.

The UDI system is expected to benefit medical device manufacturers in several ways. For example, it can provide additional information from databases operated by the FDA, European Commission (EC) and many other regulators. Furthermore, it could play an important role in inventory management. 

This could ultimately make it easier to provide high-quality medical services. Because it also could facilitate the detection of counterfeit devices.

A group of numerical and alphabetic characters know as the UDI are give to medical devices. These codes are produced in accordance with international norms and are offer in both machine- and human-readable versions. 

What is the Rule of UDI?

According to the Rule of UDI, a unique device identity (UDI) must be inscribed on the device’s label at the time of creation or modification. The creator of the device, who is frequently the labeler, may also create specifications, assemble convenience kits, or repackage goods.

The UDI system enables healthcare professionals to quickly identify devices and gather vital information. 

Who are UDI Labelers?

The Regulators mandates that all medical devices have a Unique Device Identifier (UDI) label. This unique code tracks the device’s location in the supply chain. UDI labels are required for all implantable medical devices. UDI labels are a great way to improve patient safety and speed care delivery.

To enable quick device identification and link them to other databases, the regulators including FDA, EC mandates medical device manufacturers to submit information to UDI databases.

Through a number of ways, this data will be available to the general public. The rule also offers workarounds and exclusions that allow laborer’s to comply with the new standards affordably.

If your company wants to become a UDI labeler, you should contact a UDI issuing agency, e.g. HIBCC Pakistan.

What is the UDI format?

For each device, these components need to be distinct.

Each agency has a different format for the UDI. The regulators have been required to develop new approaches for effective oversight. 

The UDI format combines the Device Identifier (DI) and the Production Identifier (PI). This format is essential for accurately identifying medical devices on the global market. UDIs must be readable by humans and machines. AIDC includes bar codes, smart cards, RFID, and biometrics. The UDI must be include on a device’s packaging, except for shipping containers.

What are the Components of UDI?

A labelling technique call Unique Device Identification services is use to identify medical equipment. The device identification and the production identifier are the two components of this system.

The production identification identifies the manufacturing environment, whereas the device identifier identifies the product. The UDI is write in plain language and must be both scannable and print on the device package. Additionally, automatic data collection and identification are require (AIDC).

An FDA-accredited issuing agency issues UDI like HIBCC.

UDIs allow regulators, manufacturers, and healthcare providers to share information about a specific medical device. This information can be use for post-market surveillance, adverse event reporting, and recalls. It also contributes to the faster detection of counterfeit medical devices.

UDIs are compose of alphanumeric and numeric characters generated through globally accept standards. Because they allow healthcare providers to track the origin and quality of a medical device. So this system has several benefits, including improved patient safety, reduced medical errors, and improved purchasing and waste disposal policies.

Who will affect by UDI?

Hospitals and medical professionals can read the Unique Device Identification System (UDI) barcode to find out if a medical device is recall or not. The method eliminates hunches and enables businesses to conduct more precise recalls.

In the past, companies have had to cast a wide net when issuing recalls because it can be challenging to know the exact date of manufacture of a particular device.

In addition to ensuring that only one device is use for a specific patient, UDIs allow medical device manufacturers to differentiate products more efficiently. Also this prevents potentially deadly mix-ups, leading to faulty medical devices. UDIs also 

ensure that expiration dates are display on individual medical devices.

What benefits of implementing the UDI System?

Several benefits have been demonstrate by organizations that have successfully implement the Unique Device Identification (UDI) system. In addition to reducing the risk of Medicare fraud, UDI has many other benefits for the healthcare industry and the public. Implementation involves teams of people and requires significant effort. To ensure success, education should be continuous and high-quality. The goal is to ensure that all staff members understand the UDI requirements.

UDI implementation will affect all stakeholders throughout the life cycle of medical devices. 

This will include patients, healthcare professionals, hospital administrators, researchers, and manufacturers. The implementation of UDI will also help companies combat the issue of medical device counterfeiting. Additionally, UDI implementation will allow companies to evaluate their product portfolios and make changes if necessary.

The adoption of UDIs is the next critical step in ensuring patient safety. Also this will enable health systems to document the devices used in patient care electronically. This information will help health systems evaluate devices and conduct research. It will also help healthcare providers provide patients with information about their medical devices.

MDR 2017/745 Consultancy and UNIQUE DEVICE IDENTIFIER UDI

As part of the new Medical Device Regulation (MDR), the EU Commission has specified standards for Unique Device Identification Systems. The Unique Device Identification is a sequence of alphanumeric and numeric characters created according to internationally accepted standards. This identification is unique to each lot or batch of medical devices and is incorporated into each machine, with registration in a European database.

HIBCC recognizes that the UDI system is mandatory for medical devices sold in the EU, although it does not apply to custom-made or performance study/investigative devices. Medical device manufacturers face a pressing deadline to comply with this system.

Our MDR 2017/745 consultancy services provide comprehensive support to ensure your devices meet all regulatory requirements, including UDI implementation. We assist you in navigating the complexities of MDR compliance, helping you understand the UDI requirements and how to integrate them into your product registration process. With our expertise, you can achieve a seamless transition to compliance, ensuring your products are ready for the EU market.