ARTICLE SUMMARY:
In this week’s Pathways Picks: Manufacturer response data from the EU’s ongoing “device availability” survey; FDA and NIH seek to clarify clinical study terms; the UK addresses artificial intelligence and digital health topics; FDA organizational updates, updates from IMDRF and Apple, and Dates to Remember.
Top Picks
EU survey, US clinical terms:
Long way to go on MDR transition. More than half of the 501 device firms responding to an EU government survey said less than 10% of their product portfolio requiring MDR certification had received it, although more progress is planned and the pace of MDR/IVD CE marks granted by notified bodies is on the rise. These are the first responses collected from devices manufactures from an ongoing European Commission survey intended to gauge device availability under the new regulations. Up until now, the research effort has focused on notified body input. For more details from the latest survey data, see in Market Pathways: “EU Survey: Most Companies Still Have a Ways to Go on MDR Transition.”
