Hi All -I have a question regarding how the documentation of the EU MDR is expected. Since there are two different Annexes for Technical Documentation(TD) and PMS TD, are they supposed to be compiled in one final submission or should it be two different submissions? Should Annex III be Part 7 to the 6 Parts in Annex II?Thank you for the help.------------------------------
Smeet Doshi
Regulatory Affairs Operations Specialist
Irvine CA
United States
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