Specifics and exceptions
Firstly, it is important to understand that during the transitional period, medical device companies were able to still place their devices on the market under the old Medical Devices Directive (MDD) until May 26, 2022. After this date, devices must comply with the MDR. However, the EU Commission has introduced Regulation (EU) 2023/607, which provides additional time until May 26, 2024, for certain devices to comply with the MDR. This extension is only available for Class I devices that are not reusable, and for Class I reusable devices that do not have a measuring function.
Although this extension may seem like a relief for some companies, it still requires compliance with the MDR’s requirements for clinical data, post-market surveillance, and labeling. Therefore, companies must use this additional time wisely to ensure their products meet the MDR’s requirements and avoid any delays in the market.
Challenges of transition
One of the main challenges for medical device companies during the transitional period is the shortage of Notified Bodies (NBs) designated under the MDR. NBs play a crucial role in the conformity assessment process of medical devices, and the MDR has increased their responsibilities and requirements. The MDR requires NBs to reapply for designation and undergo a rigorous assessment by the competent authorities. However, due to the complexity and resource-intensive nature of the process, many NBs have struggled to obtain designation under the MDR, leading to a shortage of available NBs.
This shortage of NBs has created a backlog in the MDR’s conformity assessment process, causing delays for medical device companies in obtaining certification and placing their products on the market. This backlog is expected to continue during the transitional period, and companies should plan accordingly to avoid any significant delays in their product launch.
Another challenge for medical device companies during the transitional period is the increased requirements for clinical data and post-market surveillance. The MDR requires companies to provide more robust clinical data to support the safety and performance of their devices, including post-market clinical follow-up (PMCF) studies. PMCF studies are designed to collect data on the long-term safety and performance of devices and are mandatory for high-risk devices.
Planning in advance is key to success
The MDR also requires companies to establish and maintain a comprehensive post-market surveillance (PMS) system, which includes monitoring the performance of their devices in real-world settings, identifying any adverse events, and taking appropriate corrective actions. These requirements can be challenging for smaller medical device companies that may not have the necessary resources or expertise to comply with the MDR’s requirements.
In conclusion, the MDR transitional period per Regulation (EU) 2023/607 will have a significant impact on medical device companies. While the extension for certain devices may provide some relief, companies must use this additional time wisely to ensure their products comply with the MDR’s requirements. Companies must also be aware of the shortage of NBs and the increased requirements for clinical data and post-market surveillance, and plan accordingly to avoid any significant delays in their product launch. By being proactive and prepared, medical device companies can successfully navigate the MDR transitional period and ensure compliance with the MDR’s requirements.