Medical Device Traceability Solutions

The healthcare industry whose components are not only the personnel but also the inventories is a comprehensive field with the authorities, doctors, nurses, pharmacists, and all its personnel. The healthcare industry has a wide range of products from pacemakers to band-aids, from implant screws to scalpels. The role of medical devices, which are used effectively in the treatment and diagnosis stages, is crucial in the health sector. The use of defective or unsuitable medical devices may cause irreversible problems. That is why there should be a medical device traceability system to prevent possible problems and ensure medical device safety. Developing technology and scientific studies have increased the market share of medical devices, which has led to an increase in counterfeiting. The increase in counterfeiting not only harms human health but also feeds the informal economy through damaging medical device safety.

Medical Device Traceability

According to Statista data obtained from a study conducted in the USA in 2018, it was revealed that the biggest concern of those responsible for medical device safety is patient safety. With the medical device traceability system, the journey of the products can be followed from the moment they fall into the supply chain, thus ensuring medical device safety. The use of a medical device traceability system is preferred due to the production processes, risk management, and legal regulations. While states using medical device traceability effectively ensures patient safety, companies also ensure brand safety.

The benefits of using a medical device traceability system are:

  • As the products are singularized, tracking would become easier.
  • An accurate inventory registration system would be established.
  • Effective treatment would become reachable by matching the product-patient.
  • Reporting and statistical operations would be achieved, and a strategy can be developed depending on these.
  • Counterfeiting would be preventable.
  • An informal economy would be preventable.
  • The image of the brand would be secured.
  • Production, storage, and distribution operations would be carried out efficiently.
  • Compliance with national and international regulations would be ensured.
  • With stock tracking, orders can be arranged more easily.

In addition to these, the medical device traceability system is used for recall operations. Medical device recalls should not be understood as drugs or food products. Recalls are made for device repair, control, and adjustment processes as well as for the withdrawal of the product from the market. Ultimately, all these benefits serve to protect medical device safety.

The Global Medical Device Traceability System Applications

European Union - EUDAMED

The European Union has stated the reasons for using the Unique Device Identification (UDI) system with the EU Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR) on April 5, 2017. Accordingly, studies should be carried out for medical device traceability for the development of health and medical device safety.

UDIs that singularize each product have been issued by GS1 in the European Union since 7 June 2019. The UDI application, which aims to make the use of medical device traceability systems global, is used a little more specifically in the European Union. With the UDI-DI application, products with different features under the main naming are also singularized. UDI-DI codes, which are also used as access keys to the UDI database, are unique codes specific to a medical device model. For example, the lancet number 12 and the lancet number 34 are singularized with different UDI-DI’s, and their packaging UDI-DIs are also singularized with different numbers. Apart from this, some products should also have UDI-PIs containing serial/batch number, production, and expiry date information in line with their applicability. While UDI-DI contains product information; UDI-PI contains production information.

EUDAMED Database
UDI-DI Product Serialization

Udi Boxes

Singularized product data should be reported to the European Database for Medical Devices (EUDAMED). The European Union works on the coordination, reliability, and transparency of medical devices with EUDAMED on the medical device tracking system.

The requirement to assign a UDI begins on the date that the two new Regulations take effect, which is May 26, 2021, for medical devices and May 26, 2022, for In Vitro Diagnostic Medical Devices.

The obligation to submit UDI data to the EUDAMED database for medical devices begins on November 26, 2022, and for in vitro diagnostic medical devices on November 26, 2023.

Udi Device Table
Udi Device Table

To learn more about UDI, UDI-DI and UDI-PI: What is UDI? You can read our article.

The American Food and Drug Administration (FDA) published a rule on September 24, 2013, to implement a medical device traceability system to ensure medical device safety in the United States. According to this rule, medical device labels must contain a unique device identifier. Unique Device Identification (UDI) requirements are met by GS1. GS1 was accredited by the FDA as a UDI issuer in 2013.

In the USA, the information of devices with UDI should be submitted to the Global Unique Device Identification Database (GUDID). The device labeler must have an account to access the Global Unique Device Identification Database to send information. After obtaining the GUDID account, the edited product data can be shared with the system. The FDA uses a highly functional system for medical device recalls.

Patient safety, medical device safety, and the prestige of the manufacturer are ensured by the medical device traceability system applications used by the USA. In addition, the development requirements for the medical device can be determined by following the market with medical device traceability system applications.

In 2019, China published its rules for the Unique Device Identification (UDI) system for medical devices, and gradually implemented it for the medical device traceability system. With the announcement on the effective application of unique identification, published in October 2019, necessary explanations were made for the first group of medical devices to be uniquely identified.

It is the China National Medical Products Administration (NMPA) that published the rules for the Unique Device Identification application. The regulatory body for UDI applications in China is GS1 China.

China has issued another incentive and detailed announcement regarding the unique identification for the first group of medical devices, which can be described as a pilot application, on September 29, 2020. NMPA still works on unique identification and notification for the medical device traceability system.

The Republic of Turkey, which has been using traceability systems effectively since 2010, also gives importance to medical device traceability system applications. Turkish Medicines and Medical Devices Agency (TİTCK) uses the Product Tracking System (ÜTS) for medical device traceability. TITCK has shared the details of the requirements and the application process with the guide for the registration of medical devices in the Product Tracking System. Medical device, medical device dealership, and company search can be made from the Product Tracking System portal, which has been used as a medical device tracking system in addition to cosmetic products since 2017. The primary purpose of ÜTS is to follow the processes of the domestically produced or imported product to the user throughout the supply chain.

With ÜTS, where traceability of insulin pen needles and glucose meter sticks started in 2019, medical device traceability applications of all 1st, 2nd, and 3rd class medical devices started in 2020.

As the medical device industry has a wide product variety,  both requirements and stages of serialization and aggregation should be analyzed very well. In the absence of detailed analysis, serialization and aggregation operations can cause problems in the production stages.

VISIOTT TPS offers the hardware, it has produced in line with local and global regulations for human health and brand reliability, with traceability-oriented software. VISIOTT TPS Line Manager (Level 2), VISIOTT TPS Plant Manager (Level 3), and VISIOTT TPS Enterprise Manager (Level 4) provide you with running your operations smoothly with line, factory, and business management software. VISIOTT TPS, which produces solutions for the stages of the medical device traceability system, provides after-sales care services quickly with its 24/7 support line.

VISIOTT TPS produces serialization and aggregation solutions for medical device traceability system applications regardless of medical product and device diversity. With our solutions, you can make 2D code printing and create transport unit aggregation regardless of product shape and size, packaging type.

You can analyze our solutions below and you can click here for more detailed information.








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