{"id":54128,"date":"2024-02-28T16:14:57","date_gmt":"2024-02-28T14:14:57","guid":{"rendered":"https:\/\/gs1.se\/?p=54128"},"modified":"2024-08-15T13:23:06","modified_gmt":"2024-08-15T11:23:06","slug":"to-overcome-the-challenges-in-implementing-mdr","status":"publish","type":"post","link":"https:\/\/gs1.se\/en\/blog\/to-overcome-the-challenges-in-implementing-mdr\/","title":{"rendered":"To overcome the challenges in implementing MDR"},"content":{"rendered":"\n
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The implementation of the Medical Device Regulation (MDR)<\/a> 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.<\/strong> <\/p>\n\n\n\n

The new regulatory framework <\/h2>\n\n\n\n

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).<\/a> <\/p>\n\n\n\n

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. <\/p>\n\n\n\n

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. <\/p>\n\n\n\n

The complexity of the requirements and the challenges that arise <\/h2>\n\n\n\n

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: <\/p>\n\n\n\n