Do MDD (Medical Device Directives) Devices require MDD components?

Ronen E

Problem Solver
Staff member
Moderator
#11
There's another possible interpretation of a design/manufacturing customer spec that components must be "medically approved".

Many makers of component materials and devices are gunshy about the use of their products in applications that have an adverse history regarding civil lawsuits in the event of less-than-optimal performance. Such component makers frequently impose terms of sale that attempt to establish an agreement-by-purchase not to use their products in those product types--frequently, in medical devices--and to indemnify the component maker against judgments, damage to reputation, costs of staff time, legal counsel costs, etc.

Such conditions and contractural barriers are very common in regard to two use-types...life safety systems, and implantables.

Thus, "medically approved" might refer to a component maker not establishing such constraints against medical-device use.
Sounds more like "not medically restricted"...:)
 
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alimary15

Involved In Discussions
#12
Good morning to everyone,
I am new to this forum and I found this discussion a lot similar to what I am actually tryign to search and understand.

My company want to sell to the EU market a flat panel detector based on X-Ray Imagining. These detectors can have both medical and industrial applications and my company would like to sell it not as a Medical Device, but as a "Component".

By selling it as a "Component", there will then be a third part manufacturer, that is going to assembly this device into a medical device system, thus following Article 12 Declaration, be repsonsbile for its CE requiremtns.

I would like to know what CE mark should have our detector in order to be put into market as a "component" and not as a medical device??

Hope to receive some help about this!!!

Regards,

Mary
 

Ronen E

Problem Solver
Staff member
Moderator
#13
Good morning to everyone,
I am new to this forum and I found this discussion a lot similar to what I am actually tryign to search and understand.

My company want to sell to the EU market a flat panel detector based on X-Ray Imagining. These detectors can have both medical and industrial applications and my company would like to sell it not as a Medical Device, but as a "Component".

By selling it as a "Component", there will then be a third part manufacturer, that is going to assembly this device into a medical device system, thus following Article 12 Declaration, be repsonsbile for its CE requiremtns.

I would like to know what CE mark should have our detector in order to be put into market as a "component" and not as a medical device??

Hope to receive some help about this!!!

Regards,

Mary
Hello Mary and welcome to the Cove :bigwave:

Every product offered for sale in the EC has to comply with all applicable legislative instruments: Directives, Regulations, Decisions etc. It is the legal manufacturer (entity placing the product on the EC market) responsibility to research and identify all such applicable instruments, and then comply with them all as applicable. Start here:

http://ec.europa.eu/enterprise/poli...ods/internal-market-for-products/index_en.htm

Some Directives (not all) lead to CE marking. If one of those applies to your product, you are entitled and expected to CE mark your product once you and it are compliant with all the applicable requirements. In general, the CE mark is the legal manufacturer's declaration that the manufacturer and the product are compliant with all applicable requirements, under all applicable Directives that lead to CE marking (could be more than one in parallel, for a given product).

As part of the initial sorting of applicable instruments / requirements, I recommend that you review your detector as-offered-for-sale, including all labelling and associated promotional / marketing materials, taking account of its intended use as your company sees it (and conducts accordingly), and decide whether or not it falls within the MDD's scope. If it does, you don't have a choice - it can only be CE marked as a medical device, unless you change the product and/or the labelling and/or the intended use, so as to preclude it from the MDD's scope. If it doesn't, then any other applicable CE marking route you follow will qualify it as a "non-medical-device CE marked product". In general, there is no difference in the mark itself.

I hope I managed to clarify things a little...

Cheers,
Ronen.
 

alimary15

Involved In Discussions
#14
Hello and thanks for your answer...

I am sorry I am very new about EC regulations and CE marking.

My device can have both medical and industrial applications, but my company would like to classify it as a non MDD and so avoiding to have ISO 13485 or going trought a Notify Board.

We have then another company which is developing the software for our device, which it IS already marked CE as MDD. this other company will be classified as an "assembler" and so should be responsible for integrating our device as a "component" into a medical device kit.

We just would like to sell the detector as a "imagining system" without specifying if the application its medical or industrial, because it can be for both!

I just don't know in what kind of EC Directives this panel can be classifed into.
 

Ronen E

Problem Solver
Staff member
Moderator
#15
We have then another company which is developing the software for our device, which it IS already marked CE as MDD. this other company will be classified as an "assembler" and so should be responsible for integrating our device as a "component" into a medical device kit.

We just would like to sell the detector as a "imagining system" without specifying if the application its medical or industrial, because it can be for both!
If it can't / not intended to be used as a medical device (see definition in MDD) when you supply it and as you supply it, then it's not a medical device. the fact that it can / will / intended to later be integrated into a medical device doesn't change that.

I just don't know in what kind of EC Directives this panel can be classifed into.
So maybe a little homework can help:

http://europa.eu/youreurope/business/profiting-from-eu-market/selling-goods/index_en.htm

Cheers,
Ronen.
 

alimary15

Involved In Discussions
#16
Thank you for your help!

I also suppose that it won't be classifed as a medical device, unless my company decide to sell it as a "medical" purpose device.

However, I am sure there should be some directives that apply to my product so I will be looking into the papers..


I will post back soon if (as I am sure will be ) I will have other questions!

Thanks again!
 

alimary15

Involved In Discussions
#17
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.


Any other suggestion?
 

Ronen E

Problem Solver
Staff member
Moderator
#18
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.


Any other suggestion?
Hi,

Drafting a regulatory clearance strategy for a given product usually takes me more than 4 hours, even when I have access to all required information. Sometimes I even get paid for it...;)

If you have studied the legislation to your satisfaction, and are confident with your findings, then you can proceed. The regulatory system should have enough safety mechanisms to ensure that unsafe / undue conduct on manufacturers part will be identified along the route -- if you are inadvertently doing something wrong someone with authority will tell you, sooner or later. Oversight is typically commensurate with the risk your product encompasses to the public & environment.

Regulatory specialists make their living by helping you ensure you don't get told you're doing something wrong, or at least you get told rather sooner than later (when the consequences are easier to handle).

Cheers,
Ronen.
 
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