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MDR Article 22 Interpretation

#1
Hello,

We want to sell a ventilator manufactured by combining devices bearing a CE marking, consisting of a mask, valve, filter, connectors, and oxygen line tubing. Each of the elements already has his manufacturer's CE marking and the intended use is not changed. Coupled pieces (product) are ready to use after connecting lines with oxygen tank.

In your opinion, according to MDR article 22, could this be considered as a system?

Thanks in advance for your comments.
 
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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
Help with this one will be appreciated. Thanks in advance!
 

Asia78

Involved In Discussions
#3
Yes, i agree with your assessment. In this case you want to bring to the market all those devices together and you are creating a system. All related requirements have to be followed
 

Watchcat

Trusted Information Resource
#4
I think the key phrase is in section 1 of Article 22:

"in a manner that is compatible with the intended purpose of the devices or other products and within the limits of use specified by their manufacturers"

I'm skeptical that intended use has not changed. For starters, are all of the individual devices intended for use in patients that require ventilation? Are they all intended to be used to ventilate such patients? I guess it's possible, but it seems unlikely.

Of course Section 1 doesn't say that the intended use has to be the same, only "compatible with." But when someone tells me intended use hasn't changed, and it turns out it has changed a good bit, I'm inclined to think that, when it comes to assessing whether the devices are "compatible with," they are not likely to be on target in that assessment, either.
 
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