The European Commission has enhanced its Data Dashboard, delivering fresh insights into the certification landscape of medical and in vitro diagnostic devices across the EU. This update integrates data from the 14th Notified Body survey, revealing current trends and identifying key challenges affecting device availability.
Certification Statistics
Over 28,500 applications for MDR certification have been lodged, yet only approximately 18,500 agreements have been finalized. This discrepancy suggests a potential discontinuation of legacy devices due to stringent MDR requirements. In Q1 2025, MDR Quality Management System (QMS) certificates experienced a modest rise, increasing from 4,301 to 4,500. Simultaneously, MDR product certificates surged by 318 during the same period. The IVDR certifications also showed growth, with IVDR-issued certificates up by 17% from Q4 2024 to Q1 2025.
Challenges and Future Trends
A significant obstacle lies in the scarcity of European Reference Laboratories (EURLs), with 79% of Class D certificates being issued without EURL oversight. Moreover, the average time from application to agreement spans about two months, potentially causing gaps in certification continuity for manufacturers. Incomplete applications remain the primary cause for submission rejections, indicating a need for more meticulous documentation.
– The disparity between applications and agreements may lead to reduced device availability.
– The shortage of EURLs could hinder timely certificate issuance for high-risk devices.
– Manufacturers must prioritize complete and accurate submissions to expedite certification.
– Potential innovation slowdowns are observed in specific device categories, such as brain stimulation equipment.
Manufacturers are advised to streamline their application processes to mitigate delays and ensure compliance with MDR and IVDR regulations. Addressing the bottlenecks highlighted by the EC’s dashboard is crucial for maintaining the flow of essential medical devices within the EU market.
The updated Data Dashboard serves as an essential tool for stakeholders, offering a transparent view of certification progress and highlighting areas that require immediate attention. By leveraging this information, regulatory bodies and manufacturers can collaborate more effectively to enhance device availability and meet the stringent safety standards set by the EU.
Navigating the complex regulatory landscape necessitates a proactive approach, with manufacturers needing to anticipate potential hurdles and adapt accordingly. The EC’s continued updates to the Data Dashboard underscore the dynamic nature of medical device regulation and the ongoing efforts to balance innovation with safety.
Manufacturers should also stay informed about upcoming regulatory revisions and prepare for increased application volumes, particularly for devices requiring advanced certifications. Implementing robust quality management systems and investing in regulatory intelligence can further support compliance and streamline the certification process.
Comprehensive preparation and a thorough understanding of MDR and IVDR requirements will be pivotal in overcoming current challenges. By addressing the identified bottlenecks and leveraging available resources, the EU medical device market can expect improved device availability and enhanced compliance standards, benefiting both manufacturers and end-users.
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