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:
Which seems to indicate PMCF is a requirement, without exception.
...but on the other hand, there is also the following:
Which seems to imply that there are circumstances where no PMCF can be justified.
Can anyone kindly clarify?
Thanks,
MM.
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;
(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;
...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.
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.
Can anyone kindly clarify?
Thanks,
MM.