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Is it possible for medical power supply to declare CE based on MDD?

Roland chung

Trusted Information Resource
#1
Dear all,

As you can see from the caption, my question is about the CE declaration of non-medical equipment. Is it possible for medical power supply to declare CE based on Medical Device Directive?

Thanks,
Roland
 
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S

SteveK

#2
Dear all,

As you can see from the caption, my question is about the CE declaration of non-medical equipment. Is it possible for medical power supply to declare CE based on Medical Device Directive?

Thanks,
Roland
Hi Roland,

We use a switching power adaptor from XP Power (AFM45/60) and we were supplied a EN 60601-1:2006 Certificate. However, there is no reference in the documentation I have to MDD 93/42/EEC but it does carry a CE mark as you would expect. I assume that it is CE marked under the Low Voltage Directive - but it does not reference this either.

This probably only muddy the waters.

Sorry

Steve
 

Roland chung

Trusted Information Resource
#3
Thank you for your input.

If the power supply is tested to EN 60601-1, it seems not suitable to declare CE based on the LVD directive.
 
S

SteveK

#4
Thank you for your input.

If the power supply is tested to EN 60601-1, it seems not suitable to declare CE based on the LVD directive.
Hi again Roland,

I've found a very similar certificate to the one I indicated for a similar adaptor which does reference the MDD.

http://proe-fuhua-cn.kenfor.com/dat...om/db_pictures/201112/02/1322792363817467.pdf

I assume that if the adaptor carries the NB CE number (assuming Class IIa - Rule 9) then that would prove that the CE mark is covered through the MDD. Will have to track down a label on such a unit to view this though.

Steve
 

somashekar

Staff member
Super Moderator
#5
Medical power supply (Medical grade power supply) in conjunction with the medical device constitute within the 60601-1 scope.
As a standalone they can be certified to applicable UL, CSA, and IEC/TUV standards.
It is the choice of the medical device manufacturer which makes it a medical device power supply. Power supply manufacturers consider the requirements of medical devices and application to build power supplies that can be said as medical grade / custom made to medical devices.
So I would say NO. Is it not possible for medical power supply to declare CE based on Medical Device Directive?
As always with CE stuff ... Ask NB
 
Last edited:

Peter Selvey

Staff member
Moderator
#6
It's a good question.

Basically I would say yes it's possible to CE mark under medical device directive, and without involvement of a notified body (i.e. a Class I medical device).

Although it's intended purpose is not fully specified, it would be in the same category as other broadly applicable devices, like a general purpose syringe.

The problem is, though, that the CE marker probably would not have really checked all requirements in the regulation. They most likely just did a 601-1 electrical safety and possibly the 601-1-2 EMC test, extracting the relevant clauses to a power supply, and that's it.

Those familiar with the directive would know there are a bunch of other things like marking and registering EU reps, marking date of manufacturer etc. So the absence of such marking might give a hint that it's a bit of a fudge CE mark.
 

Roland chung

Trusted Information Resource
#7
If I understand correctly, components intended to be used in medical equipment can bear the CE mark (self-declaration) if all requirements of medical device directive are checked.

I am not familiar with self-declaration. If we just have test reports and mark the CE on the label, will we be punished?
 

Peter Selvey

Staff member
Moderator
#8
You need to fulfill all the requirements in the relevant Articles and Annexes. Key ones will be Article 14 (registration) and Annex VII for self declaration. Also, you need to check the specific marking requirements in Section 13 of Annex I.

Search the directive for any reference to the "manufacturer" and/or "shall", to sure everything applicable is done.
 
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