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Proving a Medical Device is equivalent to another device from Literature Review

N

nkcsb

#1
Does anyone have any insight into proving a device is equivalent to another device (in order to establish the clinical data essential requirement for a CE mark)? Assuming you can not do side by side comparitive testing, is there another way to prove equivalence if the literature only refers to patient outcomes (as opposed to specific device performance data)?
 
#2
For my Technical files I have a section covering clinical evaluation (to cover CE requirements I quote Annex X clauses 1.1 to 1.1.3 as a preamble). With respect to equivalence – you should ask yourself ‘what is the main function of the device?’ You should already have a description for your Technical file. Once you have established this, the literature review should be straightforward. For example in my case, one of our devices provides portable medical suction (class IIa). I have managed to find 10 citations in the literature referencing similar devices or uses and included analysis of these references. It is a question of knowing about competitor products (and their clinical usage) that have a similar specification (check web sites, often you can get information there on equivalence of function – spec. sheets etc). I think in the end it is down to your justification of what is an equivalent device or family of devices from your description, function and use.:2cents:
 
N

nkcsb

#4
Thanks for the responses! It sounds like basically its a matter of writing a good story for why it is equivalent. One specific question I have - my project uses a poly material, while the similar device that I have in mind (and the only other similar device that I know of) is metal. Obviously metal is much stronger than poly, so I would not be able to claim that the material strength is equivalent or better. Is this a gamebreaker, or can I still justify it (in actuality, the fact that the material is less rigid should improve the function)? In my mind it is clear, but the question is, will an auditor or reviewer see that and question that I am claiming equivalence to a device in the literature that uses a stronger material than my device?
 

Marc

Captain Nice
Staff member
Admin
#5
I would think that would depend upon the environment it is used in and such, or if there is a reason metal is used. These days a large part of cars are plastic, for example. Think bumpers. I remember the old days of heavy chromed bumpers. I can't see a problem if you can justify why if the material is less rigid it should improve the function.
 
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