In this week’s roundup: Submissions and certifications accelerate under the EU MDR and IVDR; Data Act proceeds in Europe; House Subcommittee moves bill to establish automatic Medicare coverage for Breakthrough Devices; FDA plans panel meeting on multi-cancer tests; and more.
Editor’s note: Pathways Picks will not be published next week due to the Thanksgiving holiday.
EU applications and certifications advance:
CE marks grow. The growth rate of submissions and resulting CE mark certifications coming through both the EU Medical Device and IVD Regulations continues to climb. According to the latest notified body survey data released by the European Commission last week, NBs were granting MDR certifications at a rate of 316 per month from April through June this year, about a 64% spike from the prior five-month period that survey results were reported on. The monthly rate of IVDR certifications grew 330%, to 56 per month, during the same periods. In total through June, had certified 3,899 of the 13,177 MDR submissions and 500 of the 1,155 IVD submissions received so far. The data comes from the 39 NBs designated under the MDR/IVDR as of July. The survey continued to suggest that lack of completeness of MDR submissions coming into NBs continued to be a challenge, although the most common reasons for NBs to refuse an MDR submission is because it falls outside the scope of its designation.