UDI System and Unique Device Identification
The medical device industry, also known as the medical device industry, is another industry that effectively uses traceability after the pharmaceutical industry. Medical devices should be traceable through various methods in accordance with the regulations published. The assignment of a unique device identification, known as serialization, is not sufficient by itself to ensure traceability of the product. The UDI system is a globally developed approach that is established with specific criteria for this purpose. Before delving into the details of the UDI system, you can read our related blog article “UDI Medical Devices”
The US FDA is conducting various studies related to the UDI System. Also, the European Union has taken various actions with the Medical Device Regulation (MDR) and In Vitro Medical Device Regulation (IVDR). These two regulations of the EU classify medical devices and clear out details on traceability.
EUDAMED and UDI System
The general provisions regarding traceability of medical devices were included in the European Union Medical Device Directives. However, the approaches to traceability of countries within the EU could differ and there were difficulties related to compliance. In order to eliminate these difficulties and establish an efficient traceability system, the European Union published Commission Recommendation Document No. 2013/172 dated April 5, 2013, and work on the UDI system began. Later, the UDI system was detailed in the MDR and IVDR regulations that were published.
The benefits of a clarified traceability system with standardized inputs, outputs, and data, regardless of industry, are multi-faceted. With an effective traceability system, benefits will be realized by the manufacturer, authorities, and consumers and many existing problems will be solved. The UDI system, established with the aim of reporting the status of medical devices, quickly intervening in problems, controlling the supply chain, and facilitating the reimbursement and recall process.
Under the UDI System, product-specific device identification information must be reported to the European Medical Device Database (EUDAMED), and supplier companies must register with this system. EUDAMED is a digital portal established to track and ensure the safety of medical devices in the European Union.
Unique Device Identification Assignment and Device Classification According to the UDI System
Manufacturers may face uncertainty regarding the requirements, deadlines, and methods of assigning unique device identification (UDI) due to the diversity of their products. In this regard, classification based on risk group and a timeline will provide convenience.
Classification in Medical Devices:
Medical devices are classified into 4 risk groups:
Class I: Devices in this group are considered low-risk. Examples include bandages, compression stockings, and assistive walking equipment.
Class IIa: Low-to-moderate risk devices are evaluated in this group. They are devices that are attached to the body for a short period of time (within a 60-minute to 30-day range). Examples include hearing aids, blood transfusion tubes, and catheters.
Class IIb: Moderate-to-high risk medical devices belong to this group. Generally, devices that are installed for more than 30 days belong to this class. Examples include ventilators and intensive care monitoring equipment.
Class III: High-risk medical devices belong to this group. Examples include catheters, heart pacemakers, and prosthetic heart valves.
In vitro devices are also divided into 4 classes based on risk group:
Class A: Devices in the low-risk group for patient and public health. Examples include sample tubes and some laboratory tools.
Class B: Devices that pose a moderate patient risk and/or a low public health risk. Examples include tests/test kits used for pregnancy or cholesterol measurement.
Class C: Devices that pose a high patient risk and/or a moderate public health risk. Examples include devices used to detect the presence of infectious agents.
Class D: Medical devices that pose high risk to patient and public health. Examples of devices that detect or are exposed to infectious agents/diseases that can pose life-threatening danger.
The implementation dates of UDI codes for medical devices classified according to their type and risk group may also vary.
UDI Implementation Timeline in Medical Devices
The variety of products, due to differences in material, production method and packaging, naturally leads to differences in identification methods. At this point, VISIOTT, a company with a long history in the traceability field, comes into play with smart solutions.
Experienced Solution Partner for UDI System
VISIOTT TPS, as a global company developing solutions in the field of traceability, has also been working for the medical device industry. By considering legal requirements, patient safety, and brand reliability, VISIOTT TPS produces innovative solutions according to the variety of medical devices.
VISIOTT TPS develops affordable systems regardless of the product, risk group, packaging form, and material. It produces all its products in an all-in-one concept. VISIOTT TPS is well-known for its systems developed for the basic requirements of medical device traceability, including UDI implementation and aggregation stages. Its software, developed for management, notification, and reporting needs, is used in more than 50 countries, along with its hardware.
You can reach out to us for more information regarding the solutions and any other questions you may have, with 24/7 support service that is always at the side of customers.