PMCF (Post Market Clinical Followup): Rationale for Exemption - Software Medical Devices

#1
Hello there,

Our ISO13485 company manufactures a software medical device of class IIa and we based the compliance for the CE marking basing on equivalence.
Also, our product can be considered as "Low Novelty". We have a robust Pre-market clinical data and our conclusion (approved by BSI) on the CER is that there is no outstanding risk from Literature, and just one Risk from Pre-market clinical data which is already addressed and mitigated by our RMS, through Design&Development and V&V activities (status: Acceptable Risk).
As final comment, we do have a PMS plan (journals, trade shows, user feedback etc.) in place. The product is not on any market (neither EU nor USA) and won't be for the next 4 months due to commercial reasons.

We are at the final stage of the first CE marking issue and the auditor asked us to provide a rationale for not having in place a PMCF plan.
According to the MEDDEV 2.12/2 rev2, the only outstanding point is we based CE marking on equivalence.

I know we can be exempted from PMCF but I can't formulate an appropriate / roboust justification.
Can you please provide me with some inputs / ideas?

Thank you in advance.
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
MEDDEV 2.12/2 is N/A if the audit confirmed that your CER and RM is acceptable and there's no unacceptable residual (clinical) risk:
The objective of this document is to provide guidance on the appropriate use and conduct of PMCF studies to address issues linked to residual risks.
(Emphasis added)

Following MEDDEV 2.7/1 revision 4, your CER should have already addressed the factors giving rise to a PMCF - have you explicitly listed them and stated that (and why) they don't apply in your specific case?

Edit: The MDR makes it a little difficult to argue that PMCF is unnecessary, regardless of what you currently determine:
When conducting PMCF, the manufacturer shall proactively collect and evaluate clinical data [...] with the aim of confirming the safety and performance throughout the expected lifetime of the device, of ensuring the continued acceptability of identified risks and of detecting emerging risks on the basis of factual evidence.
(Emphasis added)

On the other hand it also says:
(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.
(Emphasis added)

I guess it comes down to the auditor's mercy.
 
Last edited:

yodon

Staff member
Super Moderator
#3
I guess it comes down to the auditor's mercy.
I think I agree... which is QUITE worrisome. I have a checklist of questions that I answer to determine if a PMCF is warranted. Yet even if I conclude that a PMCF is not warranted, a reviewer could, with no real rationale at all, decide one was necessary. They could just conclude that my rationale was not sufficient and refuse to budge.
 

dgrainger

Trusted Information Resource
#4
I can't imagine a manufacturer not having a PMCF plan.
How did you can show equivalence to a software device. Do you have access to the source code?
 

funkgirl

Involved In Discussions
#5
If you're also managing a Clinical Evaluation Report and updating at least annually and including PMS data on your device and competitors, couldn't that be considered a surrogate for PMCF in which you've definitely excluded the need for studies?
 

yodon

Staff member
Super Moderator
#6
Good point @dgrainger regarding a Plan being needed (although I don't follow the bit about equivalence to a software device). I may have been conflating Plan and PMCF Study. Indeed, it does look like a PMCF Plan would be required to define how you collect clinical data on an ongoing basis. Where it still worries me is if you conclude that a study is not necessary, it looks like an NB could just disagree and you have no real recourse.

I need to start using "PMCF Plan" and "PMCF Study" to be clear.
 

dgrainger

Trusted Information Resource
#7
I don't follow the bit about equivalence to a software device
Sorry, I miss typed. I was just wondering how equivalence had been demonstrated. I'm assuming that they have access to the source code and can prove that they are technically the same.
 
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