ARTICLE SUMMARY:
In this week’s roundup: Takeaways from new EU survey data from all MDR and IVDR notified bodies; updates from South Korea, Singapore, and China; an FDA approval achieves a real-world evidence milestone; and more from the US, Australia, and Italy.
EU Survey Picks
Takeaways from new notified body survey data:
MDR apps 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.
