Does "Similar Device" = "Predicate"?

Watchcat

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#1
So, what's the consensus so far? Does "similar device" as referenced in the MDR mean "predicate" as defined by the FDA? Anybody have this discussion with their MDR-designated NB yet?
 
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Watchcat

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#3
So true. I guess the challenge here is figuring out whose salary depends on which interpretation and which one seems to be gaining the upper hand.

"So far" means that everyone started struggling over the language in the MDR at least a year ago, and that this struggle is likely to continue for a very long time to come. So I'm just checking in to see whether any type of trend seems to be developing with respect to this one phrase. Or perhaps even some kind of authoritative resolution has been sent down from on high. :D
 
#4
In my opinion it can be predicate devices but it is not limited to them. In general I see this as a PMS obligation to know, which other devices are on the market to watch over. Since they are similar they might have the same problems as my own device. So you shall show that you understand the market so far.
 
#5
Medical device
  • 1st in the class is Non-Predicate (compared with existing platforms)
  • Followed rest in the class is Predicate (compared with Non-Predicate)
"Similar"
  • Fall under one class with same "intended use" & "design"
  • 1st in the country as Non-Predicate but internationally Predicate
  • So could be Predicate, Non-Predicate
 

Watchcat

Trusted Information Resource
#7
Is a 'similar device' different to an 'equivalent device'?
Is that a separate question? If so, then I'd be interested in getting people's thoughts on that, too. Or maybe that's actually the correct phrase? Either way.

I'm asking because someone who feels a need to know asked me, knowing I hang around in several professional forums. I'm interested in the question myself simply from the perspective of whether the EC is going to go the way the FDA on "equivalence," or whether it's going to continue to steer clear.
 

dgrainger

Trusted Information Resource
#8
Is that a separate question?
Possibly!
Equivalence is defined in Annex XIV but the regs also talk about 'similar devices' without defining them :-(
Finding an MDR 'equivalent device' seems to be a harder test than a FDA "substantially equivalent" device.
 
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