MDR - Under what circumstances is a PMCF not required?

Mark Meer

Trusted Information Resource
#1
I'm a little bit confused as to whether, under MDR, a post-market clinical follow-up (PMCF) is mandatory, and if not what kind of circumstances justify non-applicability?

The reason for the confusion, is that, on the one hand, the MDR states:
Article 10 General obligations of manufacturers
(3) Manufacturers shall conduct a clinical evaluation in accordance with the requirements set out in Article 61 and Annex XIV, including a PMCF.

Article 86 Periodic safety update report
(1)... Throughout the lifetime of the device concerned, that PSUR shall set out: ...(b) the main findings of the PMCF;
Which seems to indicate PMCF is a requirement, without exception.
...but on the other hand, there is also the following:
Annex III 1.1(b)
The post-market surveillance plan shall cover at least: ... a PMCF plan as referred to in Part B of Annex XIV, or a justification as to why a PMCF is not applicable.
Which seems to imply that there are circumstances where no PMCF can be justified.

Can anyone kindly clarify?
Thanks,
MM.
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Mark, have you searched previous threads? I think that questions of this kind, about PMCF applicability, have already been asked and answered, pretty much to the extent currently possible (in the absence of official guidance).
 
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