Upcoming NB MDD ---> MDR Crunch

Ed Panek

QA RA Small Med Dev Company
Staff member
Super Moderator
#1
Reviewing the numbers recently (Values are approximated +/-5% based on my most recent update and does not include IV Devices)

~ 200 products are MDR approved
~ 1,800 products are in MDR Review
~ 18,000 products are riding MDD approval for now

Most NB are currently very busy with the current workload.

18,000 products need to be approved. There are about 3 years to do this based on most MDD certs expiring no later than 2024.

Something will break and many devices will not be approved. I imagine the NB will take a $$ based application decision on who is left out.

Yikes.
 
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