A Focus on Quality – The Unique Device Identification System (UDI)
Ever since the US-American FDA published its final rule regarding the topic of Unique Device Identification (UDI) in the autumn of 2013, it became evident that this system will become compulsory for all producers of medical technology. Whoever intends to continue distributing medical devices in the global markets must, quite frankly, deal with this matter immediately. The UDI-System is, however, not limited to the correct labelling on the product and packaging, but in fact includes the consolidation of all medical device information in a central FDA database.
All these efforts serve the purpose of creating a uniform labelling system for medical devices that brings together the most important product and manufacturer information and displays said information in shape of a code. The FDA is, and always has been, a pioneer in this area. However, virtually all other regulated regions are now being prepared for the implementation of the UDI-system as well. It is intended that all global information that is gathered shall be saved and maintained in the FDA’s Global Unique Device Identification Database – "GUDID".
The implementation of a standardized product labelling system yields benefits for the entire supply chain ranging from the initial manufacturer via logistics right to the recipient. The patient also benefits from the system, as the precise origin and properties of the medical device that were used in his case can be easily retraced via the UDI-code. The uniform UDI-system shall, moreover, simplify product recalls, improve market monitoring, and eventually facilitate a secure supply chain all the way from the manufacturer to the customer.
The UDI-rule came into force in September 2013 and stipulated that the requirements shall apply for all class III products from September 2014 onwards. Despite its evident benefits, the implementation of such a far-ranging system proved to be rather complicated for manufacturers and the regulatory authorities. The FDA realized this too and therefore postponed the implementation due-dates for class II products by a year in December 2014.
With regard to scheduled implementation dates, there is a differentiation between the labelling on the packaging and the labelling on the actual product. The manufacturers of class II to class I products as well as implants must implement the labelling on the packaging by 2018. In a step-by-step manner, the UDI-label on the actual product will also be implemented. Here the timeframes range from 2016 (class III) to 2020 (class I). After each applicable deadline has elapsed, only those products may be put into circulation that feature a UDI label on the packaging or product respectively.
The UDI-label on the packaging is, however, not mandatory for all medical devices. The rule stipulates that the UDI must be featured on the product if the product is designed to be used more than once, is intended to be refurbished prior to its next usage, and is not subject to any of the exceptions featured in CFR §801.45(d). As these exceptions only add up to a few, this means that the vast majority of medical technology manufacturers who sell their products in the USA must have implemented the UDI-system by the applicable due-date.
As compulsory rules are also being prepared for the EU and Asia, and it is highly likely that the upcoming Medical Device Regulation (MDR) will also contain obligations relating to the implementation of the UDI-system in Europe, the topic will sooner or later affect every manufacturer of medical devices in the world. The only remaining question is when and how the system will need to be put into action. Hopefully the International Medical Device Regulators Forum (IMDRF) will compose an internationally applicable guideline that governs this process. This guideline could then be included in the individual regulations and laws.
Europe will be particularly interesting to watch: each of the 27 EU member states currently regulates the language requirements for labels and instructions of medical devices at domestic level. In what language(s) the manufacturers will need to enter information into the local Eudamed database has not yet been specified.
Expert Support for UDI-Implementation
Companies can seek expert support for the preparation and implementation of UDI. They may nominate a third party as “Regulatory Contact” for the GUDID at the FDA. This third party may then take care of the data provision process of the manufacturer. The GMP-compliance and international regulatory affairs specialist Medagent GmbH & Co. KG and the software developer CAQ AG Factory Systems are two of the few companies that provide this type of expert assistance. Together they have developed a software solution that is designed to simplify the UDI-implementation process as it permits the automated transfer of data to the GUDID. This solution furthermore reduces the risks involved in the manual or web-based usage of the UDI-system and improves overall process efficiency.
The basis of this solution is the management software CAQ.Net®. It manages the UDI-relevant data right at the master article record. This means that the information is always available in shape of an attribute and it can be automatically or manually transferred directly to the FDA’s GUDID database or upcoming Eudamed database. As the system can be directly connected to an ERP-system, there is also no need to maintain the data in more than one software program.
The functions of CAQ.Net® that are relevant for the medical technology sector were developed in close cooperation with a variety of partner companies such as Medagent GmbH who are specialized in qualification and validation procedures in the area of FDA/GMP. The resulting target/actual comparison between CAQ.Net® and the most current requirements by manufacturers and suppliers of medical technology means that the customer is always in command of a cutting-edge software solution that allows professional, efficient, and standard-compliant quality management.