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I haven't been able to come across definitive information regarding the procedure to find out whether an electronics product (PCB) requires CE marking or not.

Since it is difficult to ask hypothetical questions, let me ask by using specific examples. Let's take this RS485 IO card as a first example. Would this product require CE marking to be sold in Europe? (Maybe a similar question: would this product require any FCC approval/marking to be sold in the USA?)

Let's look at a second example. This is an A/D board. Would this product require any regulatory approvals/markings?

It would be a great help if someone with CE/FCC experience could give answers, explaining the reasoning behind those answers.

m.Alin
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SomethingBetter
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    FYI, the first board you linked to (NI PCIe-8431/16) has a CE mark under two categories: 2006/95/EC Low-Voltage Directive and 2004/108/EC Electromagnetic Compatibility Directive. I just looked it up in the manual. – tcrosley May 10 '12 at 21:48

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I don't know about CE, but you legally need FCC approval to sell a product in the US if it is a intentional radiator. If not, it still has to meet part 15 requirements, but it is up to you how you comply and there is no mandatory testing.

You can just throw a unintentional radiator out there (in the US) without testing, but if there is ever a complaint or some reason the FCC decides to test it and it is found non-compliant, then you're in deep doodoo. They can confiscate all your inventory, fine you, and even criminally prosecute you in extreme cases. If you can show you had the product tested properly and it was found to pass, the problems will be less onerous. You still won't be allowed to sell them anymore, but they might not confiscate all your inventory, there might not be fines, and probably not criminal prosecution.

A bunch of years ago there were some asian motherboards that radiated all kinds of crap. The FCC waited until one of the major trade event and made a public spectacle shutting down the perpetrators and confiscating their gear.

You may think your little product is too low volume to get on the FCC's radar. That may be true by itself, but how much do you trust your competitors? One of my customers makes a end user product that includes a RF remote, so is a intentional radiator. They went thru all the trouble to get it to meet emission standards and to get it certified. One of their competitors is importing something my customer knows is not compliant, so they filed a formal complaint with the FCC. It's too soon to tell how that will play out, but I wouldn't want to be in the other guy's shoes when the FCC finally gets around to testing and finds illegal emissions.

Olin Lathrop
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    This is fairly similar to CE. All appliances that are sold and connected to home-user grids (not industrial) require CE approval. You can self-approve CE, but if any issues are found upon investigation you're in deep trouble. Some appliances (like medical grade) require CE certification of a test house before getting anything sold, but I imagine this is also the case with FCC. If there is an incident but CE was approved, I guess there can still be legal issues but less severe. – Hans May 10 '12 at 20:37
  • Olin. Thanks for the response. I was thinking about products that are not intentional radiators. I am also confused by whether these rules and regulations apply to bare PCB products, or finished end products. I mean, suppose I design a PCB which by itself is not an end product (think of an evaluation board, or a microprocessor board as an example). Isn't it more meaningful to evaluate 'finished end consumer products' for compliance? – SomethingBetter May 10 '12 at 20:39
  • For example, TI has TONS of evaluation boards that are intentional radiators. NONE have CE or FCC certification. How does that work? Surely, TI is selling them in the US and in Europe? – SomethingBetter May 10 '12 at 20:41
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    To sort of answer my previous comment, I found this in a TI eval board documentation: This evaluation board/kit is intended for use for ENGINEERING DEVELOPMENT, DEMONSTRATION, OR EVALUATION PURPOSES ONLY and is not considered by TI to be a finished end-product fit for general consumer use. It generates, uses, and can radiate radio frequency energy and has not been tested for compliance with the limits of computing devices pursuant to part 15 of FCC rules." – SomethingBetter May 10 '12 at 20:53
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Certain categories of products must have a CE mark to be sold in the EU. One of my clients manufactures medical devices, which are of the categories specifically mentioned, so they definitely required a CE mark (and have one). However another category is Electromagnetic Compatibility. In Annex 6 of the "Guide to the implementation of directives based on the New Approach and the Global Approach" (aka the "Blue Guide") it states:

All electrical and electronic appliances together with equipment and installations containing electrical and/or electronic components which are liable to cause electromagnetic disturbance or the performance of which is liable to be affected by such disturbance.

Note this is very similar to the Part 15 requirements of the FCC (which of course don't apply to the EU), as described by Olin in his answer.

Since you can self-certify your products for a CE mark, if you are sure your product is compliant, then you can apply the CE mark to your PCB without testing. But I don't advise that.

Note there are very specific requirements regarding how the CE mark should appear on your product. They are also covered in the Blue Guide.

All the products I have designed for this client (which include intentional radiators such as cell and Bluetooth modules) are tested for EMI/EMC, and meet FCC requirements, CE requirements, and UL requirements (which audits the facilities on a periodic basis). And yes, this costs big bucks (tens of thousands of dollars).

tcrosley
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  • tcrosley: Thanks for the response. For a medical device, it makes sense, since it is an end-product. But, the examples I gave in the original post are a bit different. My view is that they are not end-products. They MAY be used in a medical device, sure, but that medical device MUST undergo testing, so there is no "risk" of having an inferior end product on the market. – SomethingBetter May 10 '12 at 20:44
  • The Electromagnetic Compatibility category is separate from Medical Devices (my client's product falls under both). Assuming the boards that you linked to would be sold as is to customers in the EU, then in my opinion you would need a CE mark. Consult an expert (like the one I linked to in a comment to David Kessner's answer to be sure. – tcrosley May 10 '12 at 20:49
  • Those boards have no functionality on their own, they are intended to be incorporated in something else, like a PC. They therefore do not require CE marking. The equipment they are used in will require it, of course. – Leon Heller May 10 '12 at 21:16
  • @LeonHeller However the board is not installed as an OEM product (if it was, then I would agree with you). Instead, the board is installed by the end user, and since the PC is not tested with the board in place, your argument doesn't hold (IMHO). – tcrosley May 10 '12 at 21:24
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The simple answer is that you should be contacting someone who is an expert on this, probably some kind of lawyer. You're asking for a laypersons interpretation of law, and that is never a good thing to do.

The quick answer is: I'm 95% sure that you will have to get some sort of regulatory certification for your example products.

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    The hope was that, there *is* an expert here. I see hundreds of products coming into Europe without any CE marking at all. Some do. Why is this all black magic? Why isn't there some sort of guideline? I would like to think that in the year 2012, we would not need legal counseling just to put a PCB product on the market? (Not to mention, I've never come across a lawyer that advertised himself/herself to be an expert on CE marking!) – SomethingBetter May 10 '12 at 20:27
  • @SomethingBetter Actually, there are companies specializing in getting a CE mark, such as [this one](http://www.intertek.com/marks/ce). A Google search should turn up more. – tcrosley May 10 '12 at 20:41