CE marking for a X-ray Imaging Detector

alimary15

Involved In Discussions
Good evening to everyone,

My company has developed a flat panel detector to be used for X-ray Imaging. We would like to sell this device but we not sure about what CE marking should be.

The device can have both industrial and medical applications.

For the medical applications, we would like to sell it to a third part manufacturer that, according to Article 12, will assembly it into a medical device system, so being himself responsible to mark the assembled system as a CE MDD.

To my company side, We would like to get a CE marking not as Medical Device avoiding so to go trough a ISO 13485 managment system and all the strict requirements that are asked for MDD.

Flat panel detectors are used a lot also in industrial applications for Imagining purpose. Can anyone help me and give me suggestions on what kind of CE marking (not MDD) is it possible to apply to the detector ?

Thank you so much
 

Ronen E

Problem Solver
Moderator
Please see my reply on another thread:

http://elsmar.com/Forums/showthread.php?p=519752#post519752

The fact that another company (a customer of yours) will use this detector as a component of a medical device does not automatically make the detector, as-offered-for-sale, a medical device. This is regardless of the route that such a customer will choose for clearing their own medical device for distribution in the EC.

You should review your detector stand-alone, along with its entire labelling / marketing materials and its intended use as assigned by your company, to reach a decision whether or not it can be considered a medical device when you supply it and as you supply it.

Cheers,
Ronen.
 

alimary15

Involved In Discussions
Hello again,

I was reading trought some EU directives....:frust:

so my panel is not a Machinery ( no part moving), is not a Low-Voltage-Device (Since it is used in radiology) ... and it can have multi-purposes (medical yes, but also indstrial,sceintific, etc) .

Let's say I want to classify it as a "general pursose" X-ray detector.

So the only applicable directive I can think of is the EMC directive of electro-magnetic compatibility that can lead me to the CE marking.



I really would not like to classify the device as a medical device. But at the same time, I think there SHOULD be some EU directives for X-ray Imaging Detectors that can be used also for not medical applications.

But in the EU website, I just find Medical X-ray applications...Am I missing something?

Is there Any other suggestion of you out there I may consider?

Thank you so much!
 

CharlieUK

Quite Involved in Discussions
is not a Low-Voltage-Device (Since it is used in radiology)

That interpretation is incorrect. That exemption applies on the basis that the Medical Device Directive would be applied instead "

If you look at the guidance to the LVD, http://ec.europa.eu/enterprise/sectors/electrical/files/lvdgen_en.pdf which states:

However, the following are excluded from the scope of the “Low Voltage” Directive:

? Electrical equipment for use in a potentially explosive atmosphere

? Electrical equipment for radiology and medical purposes


? Electrical parts for lifts


? Electricity meters,


which are covered by other Union directives, ...


Charlie
 

alimary15

Involved In Discussions
Hi Carlie and thanks for your fast Response.

So If I understand the guide and your post corrently, in case my X-ray device is not a medical device,(thus not subjected to the MDD), I can apply the Low Voltage Directive right?

thank you
 
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