Pathways’ Picks May 19: MDR in a Week, FDA on TAP, and More to Watch

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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.

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