ARTICLE SUMMARY:
In this week’s roundup: The long-anticipated In Vitro Diagnostic Regulation (IVDR) has reached its date of application in the EU; UK NICE gives a thumbs-up to its first digital therapeutic; regulatory news from India and Ethiopia; FDA launches a 510(k) sterilization pilot; HHS SUNSET rule repeal watch; labs critique VALID Act reforms in Congress; and more.
Top Pick: IVDR Day
Another big regulatory transition day in the EU:
The IVD Regulation (IVDR) is the official law of the land in the European Union as of Thursday, May 26, when the five-year transition clock for the 2017-enacted IVDR ticks to zero. What that means will vary depending on the particulars of each manufacturer and test, based on recently enacted extended, risk-based grace periods. EU policymakers have rolled out a series of guidances and other implementation documents in recent days to prepare as much as possible for the transition, even as it is widely acknowledged there is a lot more work to do. Check out two resources from Market Pathways published today:
- A run-down of the state of play for the new regulation as it stands today: “It’s IVDR Time: What’s the State of Play?”
- Our latest Market Pathways’ Scorecard infographic: The IVDR Edition
