Section 6.1 of Annex II on Tech Documentation says to include "the PMCF plan and PMCF evaluation report referred to in Part B of Annex XIV or a justification why a PMCF is not applicable."
In Annex III on the PMS plan, it also says to include "a PMCF plan as referred to in Part B of Annex XIV, or a justification as to why a PMCF is not applicable."
These seem to imply that it is possible for PMCF to not be applicable. However, there are also many other places in the MDR that says that you shall perform PMCF, implying that it is required. Does anyone know if it is still appropriate to justify PMCF as not applicable under the MDR?