ARTICLE SUMMARY:
In this week’s roundup: May 26 is a date of no return for the EU Medical Device Regulation, though it may not feel much different than today due to the MDR’s transition timelines. Also: CMS’ MCIT Is delayed and changes are coming; FDA unveils a new MDUFA V proposal for big new investments in early, frequent interactions with companies, EU finally makes progress on standards harmonization, FDA guidances roll out, and much more.
Next Picks: MDR Transition, Ain’t Over Til It’s Over
What we’re watching for:
Four years of anticipation will end a week from today with the May 26 date of application of the EU Medical Device Regulations. Or will it? Next Wednesday is a very significant milestone for the EU market, but, in a practical sense, I wouldn’t expect it to feel much different.
