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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.
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.