What is UDI
Unique Device Identification or UDI is a system that provides harmonized positive, globally and single identification of medical devices through usage and distribution. The system has two parts, which are UDI-PI and UDI-DI. The UDI-DI is the device identifier that has the power to identify a particular device within your portfolio, which is the static part of the UDI number. On the other hand, UDI-PI is a production identifier and stands out as the active part of UDI. It will tell you about the expiration date, the lot number, manufacturing date and serial number.
How Exactly Is UDI Helpful?
The UDI, meaning medical device system, stands out to be pretty helpful in many ways. To know how exactly the system is useful, please check the information below.
- Tightens the global shipping and supply chain to prevent duplication of medical devices.
- Uniform documentation for a robust pre-market evaluation for the public and the healthcare sector.
- Adequate supervision of safety-related and post-market activities, such as medical device recalls, adverse event reports and many more.
- Aggregate information related to all the medical devices to lessen human errors within the healthcare sector.
Unique Device Identification: Taking A Look At An Example!
You are well aware of UDI, but what is a UDI number? Well, to understand it in detail, an example can surely help you. The UDI comes in many forms, and the majority of the time, it comes in the form of a barcode. But a legible part should also be available, and it’s known as the Human Readable Interpretation or HRI.
You will get to the UDI-DI, and it’s the number after (01). Whenever you come across the 01 right between the brackets, it shows the placeholder for UDI-DI. The UDI-DI part depends on the product’s production characteristics, and you can easily identify some of the numbers within the UDI-DI components.
Now, let’s decode these numbers to learn about the specific information they have in-store. Look below!
- (10): This is the lot number.
- (11): This is the production date.
- (17): This defines the date of expiration.
- (21): This stands out as the serial number.
What Are The Benefits Of UDI?
Since you know what is the UDI number and what type of information it carries, now, let’s take a look at some of the benefits of the Unique Device Identification system. These benefits are:
- Improve incident reporting.
- Improves the stock management by other economic operators and various other health institutions.
- Fight against all the falsified devices.
- Lessens all the recalls.
- Magnifies waste disposal policies and purchasing.
- Lessen all the medical mistakes and errors.
Challenges You Will Face While Enforce UDI System
When it comes to the unique device identification UDI system, efficient data management stands out as one of the primary challenges. The modifications made within the medical devices will lead to the alteration within the UDI data. This might lead to changes to all the units where all such data or information is stored. Advanced techniques and tools are compulsory for the precise management of the regulatory data.
There are many international controlling establishments currently working within the implementation of the UDI systems within all the nations. You will come across the UDI-related directives, which have been declared within all the European Union member countries.
EUDAMED or European Databases and Medical Devices is the European source for medical devices. On the other hand, every nation has its own UDI medical devices. There exist incongruities among all the various national methods. This might fail to address all the globally harmonized and single systems for the identification of medical devices.
Another challenge is the different timelines for all the countries to enforce the UDI system. The difference in the timeline can give birth to various problems. The IMDRF or the International Medical Device Regulators Forum provides their help to strengthen the medical device regulatory frameworks. Doing so will become more accessible for the regulatory authorities to implement and create a uniform UDI system.
Cases When The UDI-DI Needs To Change
When the products undergo some changes, the UDI-DI you obtained for the products will go through those changes. But exactly does the UDI-DI require a change? What are the cases? To know the answer to these questions, please take a look at the information below!
- Changes in the trade name or name.
- Model or device version.
- Single or labelled use.
- Package sterile.
- The need for sterilization right before usage.
- The total number of devices within the package.
- Shade or color.
- Endocrine disruptive/CMR.
- Contra-indication or Critical warning.
Things To Know About UDI-PI
UDI-PI or Unique Device Identification- Production Identifier. So, to understand what it does, let’s say you were living in 2018 and you are manufacturing Item A Version 1.
On the first day of manufacturing, which is March 15th, you make 5 pieces. On March 16th, you can make the same product with the help of 3 pieces. Then on March 17th and March 18th, you create nothing and restart the production work from March 19th using 2 pieces.
So, what exactly do you have now? You will get this particular configuration:
- For March 15th: You will have 5 pieces along with the UDI number, which is UDI-DI A1 – UDI-PI [03.2018, with Batch Number #1]
- For March 16th: You will have 3 pieces along with the UDI number of UDI-DI A1 – UDI-PI 1 [ With the date: 16.03.2018 and Batch Number #2]
- For March 19th: You will have 2 pieces and the UDI number: UDI-DI A1 – UDI-PI 2 [Batch Number: #3 and Manufacturing Date: 19.03.2018]
UDI systems will apply to all the markets, which gets placed within the market. So, how can you be compliant within time? Well, you must practice initiating it by analyzing all the internal processor methods of your organization. You must carefully plan the methods to include the information tracking needs, UDI labelling and data submission. On the other hand, UDI systems can provide efficient target recalls, magnify patient safety, and offer excellent traceability.
Regulatory authorities have defined their own system for dealing with UDI. For instance:
If you are interested in a 510k submission you can contact us for a preliminary discussion. You can also take a look at the EU MDR UDI requirements.