ARTICLE SUMMARY:
The number of MDR submissions and certificates is trending up. Excerpted from Pathways’ Picks April 1: AI Act Deemphasized, MDR Numbers, Generative AI Approval, and More.
The rate of certifications under the EU Medical Device Regulation continued to increase last summer and autumn even as the in-flow of new MDR applications slowed. The European Commission published its most recently collected data last week from ongoing surveys of notified bodies, reporting that 2,718 new MDR certificates were issued between June and October of last year, an 18% rise in total certificates to 17,549. During the same period, the number of new MDR submissions coming in for review slightly grew, by 1%, to 33,175 applications. Look for more details from the EU’s latest survey data in an upcoming edition of Market Pathways Scorecard.