The implementation of the Medical Device Regulation (MDR) has brought about a disruptive change for manufacturers and suppliers of medical devices. In this blog post, I will explore the challenges that arise during the implementation of MDR, with a specific focus on the requirements for labeling and the reasons why manufacturers and suppliers experience time pressure.
The new regulatory framework
The European market for medical technology is regulated by the Medical Device Regulation (MDR), which came into effect in May 2021. The purpose of MDR is to enhance patient safety by applying regulations regarding what is expected from manufacturers and their products, as well as clarifying responsibilities during usage. The basic requirements imposed on manufacturers and products in MDR are largely the same as in the previous EU directives. However, something entirely new is the system for Unique Device Identification (UDI).
The purpose of UDI is to enhance the identification and traceability of products. Manufacturers are responsible for labeling products with UDI and providing the requested information in the UDI database, which is a part of Eudamed. In most cases, the format of UDI will be readable by humans and also in barcode format, for example.
Despite the MDR regulation being published in May 2017, to then come into effect four years later, both transitional provisions and application dates for the rules have been adjusted. However, the changes only apply to products that have certificates issued under the old EU regulations. This means that products covered by the transitional provisions and compliant with the requirements of the previous legislation can be manufactured and supplied by the manufacturer until 2027 or 2028, depending on the risk class of the products.
The complexity of the requirements and the challenges that arise
One reason for adjusting transitional provisions and application dates is to provide companies with more time. Thus, the EU hopes to reduce the risk of shortages of medical technology products. The challenges that companies face are numerous and some are not entirely easy to overcome. Some of the challenges that I would like to highlight are as follows:
- Complexity: MDR entails strict and intricate requirements for the labeling of medical devices (UDI). These requirements can be technically challenging and may require significant changes in production processes. The complexity of the requirements necessitates manufacturers to carefully consider and strategically plan well in advance to accommodate any changes in processes.
- Lack of resources: Many suppliers may face a shortage of necessary resources, both human and financial, to swiftly implement the required changes in the labeling process. This includes areas such as personnel training, investment in new equipment, and adaptation of existing systems. Managing these resource constraints becomes crucial for a smooth transition and to meet the new regulations on time.
- Delays in approval processes: The need for approval or certification from third parties for the new labeling requirements can lead to delays. Delays in these approval processes can directly impact the implementation timeline, further complicating the transition for manufacturers and suppliers.
- Lack of knowledge and preparation: Some suppliers may not be sufficiently aware of the new requirements or may underestimate the extent of the necessary changes. It is crucial to be proactive and stay informed about the new labeling requirements to avoid inadequate preparation and thereby difficulties in meeting the schedule.
- Changes in the supply chain: Relying on other actors in the supply chain, for example, for necessary components or materials, introduces additional potential challenges. Delays or issues with these collaborative partners can directly affect the supplier’s ability to label the products on time.
The opportunity for a smooth transition
For medical technology manufacturers and suppliers, it is crucial to manage the time pressure to meet the requirements of MDR and thereby ensure that their products can continue to be marketed and used legally. In the effort to meet time constraints and overcome the challenges posed by MDR implementation, GS1 standards emerge as a valuable tool. By embracing GS1 standards as the issuing entity for UDI, manufacturers/suppliers position themselves well to navigate through the complexities associated with MDR implementation.
The GS1 standards for UDI are globally recognized and accepted by the healthcare industry and regulatory authorities worldwide. By implementing GS1 standards for UDI, manufacturers can enhance patient safety by enabling quicker and more accurate identification and tracking of medical devices, thus reducing the risk of misuse, incorrect medication, and delayed product recalls.
However, GS1’s role extends far beyond merely meeting UDI requirements. We are actively involved in shaping and developing a standardized and efficient framework for medical devices within the scope of MDR. Our GS1 standards enable not only better compliance with regulations but also increased interoperability, improved data quality, and overall efficiency throughout the supply chain.
Author: Olivia Karringer, Client Manager, GS1 Sweden
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Olivia Karringer, Client Manager, GS1 Sweden