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Where to draw the line for "sufficient evidence" to verify safety/performance of a device?

#1
Hi,

Sorry in advance if this is long-winded. I'm having trouble understanding the limits people (mainly notified bodies I suppose) set for determining whether there is sufficient clinical evidence to verify safety/performance of a device. Is it just a judgement call on a case-by-case basis? Is it ever OK to have zero evidence of one type if you have tons of evidence of a different type? For instance, what if you had zero PMCF but hundreds upon hundreds of articles in the literature? What about vice versa, with nothing in the literature (even with really broad search terms) but a lot of PMCF information available? Same question goes for any other combination you can think of (eg, lots of FMEA, some literature, no PMCF, a little bit of MAUDE/MHRA/TGA-DAEN or whatever else). Some related questions:

a) If you're doing an update, do you need recent verification/validation/FMEA data if no design changes were made since the last evaluation period? Can you just say "it worked last time so that old data is sufficient"?

b) Are non-peer reviewed abstracts sufficient evidence if no peer-reviewed literature is available? Can they be a tie-breaker where you're on the borderline between "sufficient" and "insufficient" and they tip you over the edge to "sufficient"?

c) Can absence (or near absence) of information be used to support your conclusion? If you receive no complaints and nothing shows up in databases like MAUDE (and others), would you consider that to support the safety of your device? What if a previous evaluation period had none but the current evaluation period has a small (subjective, I know) amount? It's at the mercy of what people report to you so there's no real way to know how representative the previous or current periods were.

d) What happens if you ultimately decide there's insufficient evidence? Do you just tell the notified body "hey our device isn't safe/effective" or "hey we're not really sure and need more info" then get reprimanded, lose the CE mark, and forced to take your device off the market? Seems like there would be pressure to make data "fit" into being sufficient if that's the case.

If you made it this far, thanks for any info/insight!!
 
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#3
Well, you should start your (continually ongoing) clinical evaluation process early during development. You will then see in time where there is sufficient data in the literature, and where you need to create more data.

If you closely follow the MDR requirements(*) for the clinical evaluation plan (CEP, see MDR Annex XIV 1. a), you will have a list of your device "clinical outcome parameters", with measurable aspects. You then should dissect every piece of data you found (literature, PMS, PMCF, registers, HTAs, ...) for these aspects. You do the same for the current state of science and medicine. Since you are trained in scientific research and writing (MDR requirement), you can compare these aspects for your device (including equivalent devices) and the state of the art and evaluate if there's a significant difference, or if you have not enough data to determine significance.

MDR Annex XIV 2.:
"... Its depth and extent shall be proportionate and appropriate to the nature, classification, intended purpose and risks of the device in question, as well as to the manufacturer's claims in respect of the device. "
This allows you to justify to use few data for an old, simple class IIa device and requires you to really dig deep for your new class III device with game-changing features.

There's no need to have data from all possible sources, but you should justify why you used the sources you did, or show that you found no data. That's especially common with competent authority databases. You search with FDA MAUDE, Health Canada and TGA and will receive a nonconformity for forgetting the european databases. If you add MHRA, Swissmedic, BfArM, and still find no data (using the right keywords, not just your company name), you're actually lucky to have no data.
In the long run, however, you should have a very good reason not to have PMCF data. Keep in mind that PMCF need not be a PMCF trial. But the NB will want to see data from your own device sooner or later.

You also need to be aware that, although the demonstration of equivalence under MDR sounds equal or even easier that under MEDDEV 2.7/1 rev4, you have to show how you got access to the data you compare. That can include the other devices IFU, data sheet, homepage, literature, but also own lab analysis. There's always a chance that you cannot show that for some critical aspect, e.g. the exact surface treatment of the implant that's supposed to facilitate bone integration.

(*): Don't forget to add the MEDDEV 2.7/1 requirements to your CEP.
 
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