Pathways' Pick of the Week: MDR Applications Accelerate

The average number of EU Medical Device Regulation applications flowing into notified bodies each month has more than doubled since last fall, according to notified body survey data posted by the European Commission July 25. The data comes out of an EU-funded effort to create a public dashboard of MDR and IVDR performance metrics as previously reported by Market Pathways. It incorporates responses from all 39 notified bodies that have been designated to operate under the MDR and IVDR. As of the end of March, the bodies say they’ve received a total of 11,418 MDR applications, which means they have come in at an average rate of 660 per month since the Commission last reported this data in October, up from about 322 per month during the prior six-month period. During the October-March period, the bodies granted certifications at an average rate of 192 certificates per month, up from 155 per month during the prior six months. In total, notified bodies had granted 2,951 MDR certificates as of the end of March. The data doesn’t distinguish between legacy devices operating extended transition periods and devices seeking EU market access for the first time.

The total time it takes for notified bodies to complete a full MDR assessment varies across a broader range compared to what they reported to the Commission last October. At that time, 82% of assessments that included both Quality Management System (QMS) and product certificates took between 13 and 18 months to complete (and the other 18% took between 19-23 months). But including QMS-plus-product certifications granted through March, about 45% were completed in 13-18 months. Another 30%-plus took 19 months or longer (including some that go beyond two years) and almost 25% took less than a year.

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