With the universal trend about application of medical devices’ UDI, and industry requirements in the Union, the EU Commission has specified its requirements explicitly concerning the implementation of the UDI (Unique Device Identification) System in the last publication of the new (IVDR) In Vitro Diagnostic Medical Device Regulation 2017/746 and EU (MDR) Medical Device Regulation 2017/745. Both were issued in the early 2017. Both regulations clarify the requirements on both categories of devices. But the implementation dates for the two regulations are not same. As for the old EU Medical Device Directive (MDD), it has no section for the traceability of the medical devices in terms of UDI however the new MDR in the EU market has requirements for the UDI and traceability. Numerous companies regarding the medical devices are also working hard to acquire sufficient information about the new requirements on medical device traceability & identification.
Medical device manufacturing companies in Europe are now exposed to the challenge of adjusting their systems to the novel EU UDI requirements as it will influence them in different means including process-based, and technical aspects of manufacturing. Alternatively, there will be sufficient advantages for businesses for example better inventory control, improved response against an adverse event etc. The new requirements also empower companies to deal with deception, and make a transparent procedure within the supply chain of medical devices. Below is a crash discussion on different elements of Unique Device Identification (UDI).
Important UDI Elements
UDI (Unique Device Identifier)
The UDI is composed of both alpha and numeric characters
The UDI is composed of two different elements:
Device Identifier (DI) is associated with the static data. The DI is globally unique; it is the entry key to information stored in a EUDAMED database. The DI will persist to be unique at every phase of packaging for a specific company and medical device.
Production Identifier (PI) is associated with the dynamic data. The PI incorporates valuable information for instance product expiry code, lot or serial number and batch etc.
A UDI is embedded in the medical device itself, within its IFUs and even on its packaging. But for a device singularly packed has its own UDI compared with the same device which is packed in multiple numbers should have a different UDI. It means number of devices grouped together in a packaging should have their own UDI. Minimally, a new UDI is mandatory whenever there is a change that could lead misinformation in identification or traceability of the medical device.
UDI Carrier or Transporter
The UDI Transporter (also known as carrier) is made up of DI + PI in two different formats:
- Machine (Automatic Identification and Data Capture Technology – AIDC)
- Human readable form (Human Readable interpretation – HRI)
The AIDC Data Transporter is engineered on the basis of ISO standards concerning the data matrix, bar code, or RFID etc. and complies with coding standards which are globally acknowledged such as GS1 or HIBCC. The AIDC format is essential at any time where there are acute space constraints on the device or on its packaging.
The HRI Label is needed within the distribution channels and in the healthcare facilities.
When there are several bar codes applied on the same package, the UDI carrier should be easily distinguishable. It means that a worker in the industry can recognize UDI among other different bar codes. The UDI Carrier should be legible in normal routine and within the envisioned lifespan of the medical device; this comprises of the sterilization for re-usable devices and the reprocessed devices. The UDI for different situations related to its lifecycle is discussed as:
- For reusable or reprocessed devices, the UDI should be identifiable after the additional processes. The UDI on the device should incorporate the information of supplementary processes for reprocessing.
- In the instance of device implants, the UDI is supposed to be identifiable before implantation.
- In the reality of Medical Device Software which is Standalone, the UDI is embedded at the system level.
EUDAMED – UDI Database
For incorporation of a medical device in the UDID or EUDAMED, the manufacturer shall incorporate into the system the UDI data also the UDI-DI and other important data elements related to it. At the beginning step, it does not comprise of the UDI-PI or any other specific information. The core and significant data elements will be obtainable for the public (without any fee); they are the minimum information required to identify a device through supply chain and its application. The manufacturer is liable for staring submissions and updates related to the data.
Data on novel UDIs must be available at the time; device is determined to go in the market. It is imperative to realize that merely the presence of a medical device in the EUDAMED does not mean compliance of the device with the regulation, but only exhibits that the procedural requirements have been complied.
Alysidia – Manufacturers’ Plan for Compliance & Success
Now it is evident that these requirements are difficult to manage if the organization is doing all on its own. Alysidia has simplified the process for UDI placement, embedding it in integrated solutions such as QA, PMS, supply-chain, and even in the electronic IFUs etc. Alysidia comes with different reporting tools, information sharing options, robust privacy, and compliance with various regulations. Alysidia offers customized solution that meets industrial expectations along with specific customer expectations.
The system of Alysidia is designed with high-tech solutions such as block chain to ensure error proofing and full traceability throughout the supply chain of the medical device and pharmaceutical products.