Medtech Magazine: IVDR Certificate Progress Faces Significant Hurdles in 2025

As of February 2025, approximately 1,500 IVDR certificates have been issued. However, with an estimated 18,700 devices still requiring certification before the 2029 deadline, a significant challenge remains. Current certification rates project that only approximately 7,500 certificates will be granted by 2029, potentially restricting market access for numerous products. To avoid this shortfall, the industry must accelerate its certification efforts threefold to fourfold. Data indicates that manufacturer readiness is a primary bottleneck. Surveys reveal that 61% of the total certification timeline is attributable to manufacturers' internal processes, such as documentation and technical file preparation, rather than notified body review. Combined QMS and product certification timelines typically range from 13 to 18 months, with some cases extending to two years, highlighting the critical need for improved manufacturer preparedness.