Hello Peter,
Reading through the guidance document as a whole and specifically your question regarding those two areas. To address the first, the "break" in the table at Rank 4 and 5 for me the statement is quite clear if Class III or implant legacy devices are not Well Established, or no justification for this, seems like a "clinical study" of some sort would be required for the device - full prospective study, completed study by someone else, or even a survey. Regarding the second question what is a 'high quality survey' could mean a few different things, but I see this high quality survey as something generated by the company to gather safety and performance information proactively or actively from the existing customer base. With that said, I can see there would be scepticism using this method, but it is a Rank 4 according to the list. If we think about a legacy device maybe having been on the market for a 5 - 10 years, CE Marked under the MDD, maybe a couple literature have been published with decent information on the device. The question is do we have sufficient clinical evidence? How I read the ranking list in the guidance - and it just a guidance remember - the company has already been doing prospective customer surveys over a few years and continue to plan to do so gathering safety and performance feedback on the device, state of the art, and intended purpose. Now some may argue this actually falls into the realm of a Performance Clinical Follow-up (PMCF) being a post market activity, which may be a valid assessment as well. If just looking at Annex III the idea being there are multiple clinical data sources which need to be reviewed and examined for apply to existing legacy device clinical evidence.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 29-Sep-2020 15:52
From: Peter Miko
Subject: MDCG 2020-06 evidence rank 4.
Dear Colleagues,
in the table in Annex III. of MDCG 2020.06 it is stated, that "Class III legacy devices and implantable legacy devices which are not well-established
technologies should have sufficient clinical data as a minimum at level 4."
In the considerations/comments to level 4. it is stated, that "High quality surveys may also fall into this category".
How do the native English speakers interpret this important statement?
What is the meaning of "high quality survey" according to your understanding?
Thank you and with best regards
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Peter Mikó M.D
ArtPharm Ltd.
Gyermely
Hungary
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