Can YOU help? --> Unanswered questions <-- (Other than Marcelo's Informational posts)

EU MDR 2017/745 Rolling Plan

#2
For a company in UK, still waiting on a Brexit decision and having moved our NB to Europe, this Rolling Plan is a very useful reference.
Would you know if there is a comparison table of the variations between 21CFR820 and MDR?
 

Ronen E

Problem Solver
Staff member
Super Moderator
#3
The FDA has announced that they intend to begin moving away from part 820 and towards ISO 13485 in late 2019. The MDR is aligned with ISO 13485 (although it's not yet officially harmonised under the MDR - no standard is, yet), so pretty soon there will be no gap.
 
#4
Thank you, that's useful to know. What is the driver for the FDA's move towards ISO 13485, is it alignment with the MDSAP format, and how long is the transfer planned?
 

Ronen E

Problem Solver
Staff member
Super Moderator
#5
The driver is better alignment with the rest of the world.
I'm not currently aware of a rigid finish line, but I gathered that the transition will span 2-3 years.
 

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