Hi all,
I realise this has been touched on quite a bit already, but there seems to be conflicting opinions on how to handle PMCF, so just hoping someone can put me straight before my head explodes.
First off, comments in some of the threads (like this one: Clinical Evaluation Plan vs. PMCF Plan) seem to suggest that the Clinical Evaluation drives a decision as to whether or not PMCF activities are required. My understanding of the discussion is that in situations where the Clinical Evaluation raises specific questions that may impact the existing benefit/risk ratio, then this tells you that PMCF is required and so you need to generate a PMCF plan to look into it further. On the other hand, if no such safety/efficacy questions arise in the Clinical Evaluation, then you can you just ignore PMCF activities altogether (at least until new info comes to light that would force you to re-evaluate). But until that happens we can just move through the product's life-cycle without any PMCF plan/evaluation/report (using a justification as seems to be invited per Annex II 6.1(d)).
But then there's some really good disucssion which seems to contradict this approach, like in this thread: Interesting Discussion - PMCF (Post-Market Clinical Followup) vs PMCF studies. This seems to suggest a PMCF process is always (mostly?) necessary and that a PMCF plan is continuously being adhered to in the background, like with PMS. The first approach makes more sense to me, as I don't quite get what a PMCF plan without PMCF studies would give you that couldn't be captured through the Clincial Evaluation plan. Leaving that aside however, this 2nd approach does seem to tally closer to the letter of the MDR, so I'm concerned that the first approach could be viewed as non-compliant (even though I think it would get you to the same end result with one less round of plans/reports).
So I'm wondering what people generally do - in cases where the Clinical Evaluation is saying everything's good, nothing to see here, would you simply justify no PMCF? Or would you still generate a PMCF plan and periodic reports regardless? Or maybe the MDR is sufficiently vague/confusing that you could use either approach until consensus practice emerges?
Thanks in advance,
Damien
I realise this has been touched on quite a bit already, but there seems to be conflicting opinions on how to handle PMCF, so just hoping someone can put me straight before my head explodes.
First off, comments in some of the threads (like this one: Clinical Evaluation Plan vs. PMCF Plan) seem to suggest that the Clinical Evaluation drives a decision as to whether or not PMCF activities are required. My understanding of the discussion is that in situations where the Clinical Evaluation raises specific questions that may impact the existing benefit/risk ratio, then this tells you that PMCF is required and so you need to generate a PMCF plan to look into it further. On the other hand, if no such safety/efficacy questions arise in the Clinical Evaluation, then you can you just ignore PMCF activities altogether (at least until new info comes to light that would force you to re-evaluate). But until that happens we can just move through the product's life-cycle without any PMCF plan/evaluation/report (using a justification as seems to be invited per Annex II 6.1(d)).
But then there's some really good disucssion which seems to contradict this approach, like in this thread: Interesting Discussion - PMCF (Post-Market Clinical Followup) vs PMCF studies. This seems to suggest a PMCF process is always (mostly?) necessary and that a PMCF plan is continuously being adhered to in the background, like with PMS. The first approach makes more sense to me, as I don't quite get what a PMCF plan without PMCF studies would give you that couldn't be captured through the Clincial Evaluation plan. Leaving that aside however, this 2nd approach does seem to tally closer to the letter of the MDR, so I'm concerned that the first approach could be viewed as non-compliant (even though I think it would get you to the same end result with one less round of plans/reports).
So I'm wondering what people generally do - in cases where the Clinical Evaluation is saying everything's good, nothing to see here, would you simply justify no PMCF? Or would you still generate a PMCF plan and periodic reports regardless? Or maybe the MDR is sufficiently vague/confusing that you could use either approach until consensus practice emerges?
Thanks in advance,
Damien