As the result of the universal trend about application of medical devices’ UDI, The EU Commission has stated its requirements clearly regarding the use of the UDI (Unique Device Identification) System in the last publication of the new EU (MDR) Medical Device Regulation 2017/745 and (IVDR) In Vitro Diagnostic Medical Device Regulation 2017/746. Both were released in the start of May, 2017. Both regulations explain the requirements for both devices’ category are same. However the implementation timelines for the two regulations are different. As the old EU MDD (Medical Device Directive) has no clause for the trace-ability of the medical devices however the new MDR in the EU market has requirements for the trace-ability. Many companies concerning the medical devices are also trying to get more information about the new requirements on device identification and traceability.
Manufacturers now face the challenge of adapting their systems to the new EU UDI requirements as it will affect them in many ways including procedural, managerial and manufacturing aspects. On the other hand, there will be plenty of benefits for businesses such as improved inventory control, better management for an adverse event etc. The new requirements also help to minimize deception, and create a transparent protocol within the supply chain of medical devices. Below is a brief explanation on different aspects of Unique Device Identification (UDI).
Important UDI Elements (EU MDD)
UDI (Unique Device Identifier)
The UDI is a series of alphanumeric and numeric characters.
The UDI comprises two units:
Device Identifier (DI) is related to static data. The DI is internationally unique; it is the entrance key to information placed in a UDI database. The DI will remain unique at every phase of packaging.
Production Identifier (PI) is related to dynamic data. The PI comprises of information such as lot or serial number and product expiry.
A UDI is allocated to the medical device itself, or its packaging; increased packaging levels should have their own UDI. At the least, a new UDI is needed whenever there is a modification that could result in misinformation in trace-ability or the identification of the medical device.
UDI Transporter or Carrier
The UDI Carrier comprises of DI + PI in a machine (Automatic Identification and Data Capture Technology – AIDC) and human readable form (Human Readable interpretation – HRI).
The AIDC Data Carrier is built on ISO standards regarding bar code, data matrix, or RFID etc. and adheres with coding standards which are internationally recognized such as GS1 or HIBCC. The AIDC format is useful whenever there are critical space constraints on the device or its packaging, but,
The HRI Label is required within the distribution channels outside healthcare facilities.
When there are numerous bar codes applied on the same package, the UDI carrier should be easily identifiable. It means that a person in the industry can identify UDI among other bar codes. The UDI Carrier should be readable in normal use and within the intended lifetime of the medical device; this also includes the sterilization for re-usable devices and the reprocessing of the medical devices. The UDI for different cases concerning lifecycle perspective is listed as:
- For reusable or reprocessed devices, the UDI should be marked after the additional processes and the UDI on the device should have the information of additional processes.
- In the case of device implants, the UDI is meant to be recognizable before implantation.
- In the case of Medical Device Software which is Standalone, the UDI is allocated at the system level.
UDID – UDI Database
For registration of a medical device in the UDID, the manufacturer shall offer the UDI data also the UDI-DI and other important data elements related to it and the device specifications. At the initial stage, it does not include the UDI-PI or any other confidential commercial information. The core and important data elements will be accessible to the public (without any fee). The publicly accessible data are the least data elements to recognize a device through supply chain and its usage. The manufacturer is responsible for initial submission and updates of the data. Data on fresh UDIs must be accessible at the time the product is opted to go to the market. Modifications to a data element do not need a new UDI; however one should request an update of the UDID data within thirty days. It is important to realize that the presence of a medical device in the UDID does not mean compliance of the device with the MDR regulation, but only shows that UDI procedural have met.
The European EUDAMED database is still in process, and its actor registration module is now available. Therefore, manufacturers and any operators with labeling responsibilities should act proactively to understand the dynamics to submit EU UDI as per the new regulations. TS Quality & Engineering white paper provides a Step-by-Step Guide for organizations operating in the Europe to move for the preparation of European EU – UDI compliance issues.
Medical Devices Manufacturers’ to Plan for Future Success
These new and complex EU labeling requirements, regarding the EU UDI submission and the labeling on products, pose foremost concerns for manufacturers looking to start or continue with their medical device businesses under the prospective MDR in the EU. As such, it is extremely important to have a well though strategy as per organization’s context that will facilitate successful implementation of the updated UDI system and its compliance requirements.
Companies now need to think and plan well to implement the change from now onwards, and act accordingly. Organizations with this new EU UDI will also have the prospect and benefit to improve existing data systems and labels at all processes. Well established processes will help company’s readiness to comply with new labeling requirements, focus on the pre-clinical and clinical data and improve post-market surveillance activities for the upcoming MDR. TS Quality & Engineering can help organizations with the preparation of MDR as well as with the compliance issues related to EU UDI submission and associated labeling requirements. Therefore companies and professionals can request TS Q&E White Paper titled as “Step by Step Guide to European UDI Preparation & Compliance” and also call TS Q&E to know more.