Does an Outside Steam Generator need to be Registered in the EU?

rangani_rj

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#1
Hi All,

Do we need to register steam generator as medical device?

Confusion is that some large sterilizers approved in EU have integrated small steam generator but in our case it is placed outside of premises and steam is then transported to sterilizer (small, large, stations). Steam is also used for other purposes, only small part of which is used for sterilizing medical device.

I also found that Pressurized Equipment Directive (PED) is applicable to this unit (as pressure is above 0.5 bar) and it also requires CE marking. Could we use this directive (if MDD is not applicable). Again second question arises here "can we include PED complied device (generator) while showing conformity for MDD device (steam sterilizer)".


I will be grateful who can assist and thanks in advance
 
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pog451

#3
I have no experience with medical devices but I can certainly confirm that your device will be subject to the PED. Don't forget that any piping from the steam generator to your device and other distribution points is also subject to PED.

There should be no problem issuing a CoC to PED and including any declarations of conformity to other directives. It is also perfectly possible for your unit to be subject to two or more directives at once.

If you haven't had much experience with the PED, be aware that CE marking to that directive is not a banal problem. there is also the issue that the ultimate "owner" (and thus CE-marker) of the system will be whoever finally connects it up. If you just supply the generator and piping but it is installed and commissioned by a final user, you may not be the "manufacturer" in the eyes of the PED and and may not be responsible for the CE marking.
 
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