CE Marking Directives and standards.

[pope]

This whole CE thing is so confusing that it drives me nuts and i'm sure I'm not the only one out there...

Can someone with knowledge on this topic help me a bit pretty please?

How is it possible to find out what directives are needed for a specific product? And even if the specific directives are known, how the heck do you know what standards you should follow? Every manufacturer seems to use different standards for almost identical products.

Speaking os standards, they seem to be updated all the time. Does this mean that you have to go through the whole process every time there's a update?

And a last one. My understanding is that LVD is required for 75-1.5k Vdc operation. Assuming you have a product that accepts multiple dc voltages from an external power supply. Let's say +/-24Vdc, +48Vdc, +12Vdc.  Does this unit fall into the LVD directive or only under the EMC directives?

Any help is much appreciated! 

[jonpaul]

Bonjour cher Monsieur Pope,

We designed, manuftured,and consulted on EMI, safety and complice in avaition, telecom, broadcast  and medical equipment since,1980s.

Compliance is a wide,field and requires some specialized lab equipment and technique.

Both legal, customs,and safety is at risk.

Agencies like VDE, TUV, in EU and ETL, UL in US provide compliance design and testing as a service.

For a production product determine if it is SELV under 42.2V peak, mains operation or battery to categorize.

Besides the safety CE, sales into EU must complete with RoHS, WEEE, EMI and mains power harmonics.

Expect a fully compliant product to take 6..12 months, and cost $10k....1M depending on are a of applications, voltages, etc.

Using a CE/UL rated wall transformer so only isolated AC or DC below 42.2V peak can relieved your product of some of the issues.


I would not rely on a forum for solutions.

Suggest you consult with a professional compliance firm, and not DIY this problem.

Or just drop the product idea.

Bon   Chance

Jon

[Siwastaja]

How is it possible to find out what directives are needed for a specific product? And even if the specific directives are known, how the heck do you know what standards you should follow?

You should just hire a consulting firm to do that. Expect to spend thousands of hours in this rabbit hole without. A few thousand € will help you bypass all of this. Expect to spend money in EMC lab anyway, so it's not a huge difference. The same houses that do EMC can help with consulting, too.

If you are going to make a low-cost product for small niche/hobby market so that you can't allocate for the cost, then just sell them illegally without all the CE/EMC hassle, no one cares if it's just a few.

If you sell an external plug-in wall wart without mains wiring with your product, something which comes with CE label and which outputs SELV voltages, then LVD does not apply to you.

[Benta]

Taking this seriously, these links may help:
https://single-market-economy.ec.europa.eu/single-market/ce-marking/manufacturers_en
https://europa.eu/youreurope/business/product-requirements/labels-markings/ce-marking/index_en.htm

You'll most likely need to prove conformance to:
LVD
RED
EMC
directives.
Additionally, fire hazards etc. may come on top.
RoHS always, of course.

[switchabl]

Taking this seriously, these links may help:
https://single-market-economy.ec.europa.eu/single-market/ce-marking/manufacturers_en
https://europa.eu/youreurope/business/product-requirements/labels-markings/ce-marking/index_en.htm

Yes, if you really want to figure out which directives and standards to apply, this is the place to start. I personally think it's not a bad idea to have at least some understanding of what's involved, even if I agree that you should absolutely hire a specialist.

The first link basically lists all directives that are relevant to CE and you need to go through all of them and decide if they apply to your product (which is often very obvious and sometimes not at all). The ones specific to electronics are:
- RoHS (always)
- EMC (almost always)
- Low Voltage (highest voltage rating on both inputs and outputs 50-1000 VAC or 75-1500 VDC)
- Radio Equipment (intentional transmitters)
- Ecodesign (specific product categories specified in a number of "implementing measures", most important is 1275/2008 which limits standby/off power consumption for products listed in Annex I)

But of course, other directives may still apply to electronics, e.g. a radio transmitter may be part of a toy. Or a product may have a motor and also be covered under the machine directive.

There are also other important directives that are not directly relevant to CE marking (and do not appear in the DoC) but you still need to apply, specifically:
- General Product Safety (all consumer products)
- WEEE (almost all electronics)

Once you have identified the directives, you can look through the list of harmonised standards to find the ones that best match your product. For example, here you can find the table of standards for the LVD: https://single-market-economy.ec.europa.eu/single-market/european-standards/harmonised-standards/low-voltage-lvd_en (bottom of the page)
Your product needs to comply with the current directives and harmonised standards that you rely on at the time product is "placed on the market". You can keep making and selling it as those are updated (unless changes are explicitly applied retroactively; this is rare). If you make a significant change, you need to re-certify compliance to current standards.

Finally, if you really, really want to go down the rabbit hole, there is the infamous "Blue Guide": https://single-market-economy.ec.europa.eu/news/blue-guide-implementation-product-rules-2022-published-2022-06-29_en

[pope]

Thank you for the replies.

I realise that contacting a consulting firm is the best way but what I'm looking for at the moment is some general information. I've been reading everything I can find online for the past three days so you can imaging how frustrating this can be. I'm pretty sure most of you have been there, done that...

Spending 10k-1M is not an option by any means as we're talking about a few units per year in a niche market. However I wouldn't call the product "cheap". Also, we are talking about an all analog device with a linear power supply so hopefully the EMC tests should be on the less complicated side (?). 

Since the power supply will be on a different enclosure I guess I would need to go through this mess twice but my question is will I need to do LVD on both units? The main unit will receive multiple DC voltages from the power supply. Something like +/-20Vdc, +25Vdc, +12Vdc for example. Does this fall under the LVD (75-1.5k Vdc) requirement?

[jonpaul]

 Few units/yr...Not worth the time   To read the STDs and interpret  years to really understand

Use a off the shelf SMPS power supply, WITH genuine CE/UL approval (NOT illegal Chinese knockoff)

Medical use: Specials requirements

Expect issues if shipped over a frontier eg from EU><UK EU><USA

Regardless of voltages, need  compliance for EMI, RoHS, WEEE

Jon

[bookaboo]

Get a quote from your local test house, even if you don't get the testing done with them they will give you a list of the standards you need to comply with. You could pick and choose which ones you want to do properly (would be better than doing none).

EMC immunity in particular can be a great stress test of an analog device.

[tszaboo]

Spending 10k-1M is not an option by any means as we're talking about a few units per year in a niche market. However I wouldn't call the product "cheap". Also, we are talking about an all analog device with a linear power supply so hopefully the EMC tests should be on the less complicated side (?). 

Just doing RED, EMC and LVD testing could easily cost all together 10KEUR . Though you might be able to find some local labs that could be cheaper than that. Then you have access to the Europen market.
What you need is really dependent on the product you make. For electronics, it's what others said. LVD, EMC, WEEE, RoHS. If it has a radio then you don't do EMC, you do RED.
Notice that these are not a single tests. The EMC directive covers dozens of standards that can be applied to your product based on what it is. A plush toy will have different EMC requirements than something that goes into an industrial environment. Once you identified which directive you need, you still have to figure out which standard to apply and in that standard, what level to use. Is it IEC 61000-4-4 level 1 or level 4? They have to setup the test differently in each case, and it's applicable to different equipment. So it's actually 3-4 levels down the rabbit hole you need to go.
Directive-> Standard -> levels in the standard. Often times multiple standards for the same directive.
You want to have a good idea what you need? Get a competing products "Declaration of Conformity". It's an A4 page that should list all these. It's not easy, and honestly, should be defined before you start a product, but the average manager is so clueless about how a project should be handled, I'm not even surprised anymore.

[switchabl]

Since the power supply will be on a different enclosure I guess I would need to go through this mess twice but my question is will I need to do LVD on both units? The main unit will receive multiple DC voltages from the power supply. Something like +/-20Vdc, +25Vdc, +12Vdc for example. Does this fall under the LVD (75-1.5k Vdc) requirement?

One box != one product. From the way you describe it, the power supply and the main unit should almost certainly be considered sub-assemblies of a single product and would be tested and certified together. Presumably under both EMCD and LVD (assuming the power supply is mains connected and you don't have a radio trasmitter).

[Barry Hardhouse]

Hi, agreed - compliance is a nightmare.
There is a reasonable book "CE Marking" by Chetan Kathalay which is at least somewhat readable.

To your specific case of a product with an external power supply, also of your design, I think you would want to handle this as a single product in two boxes. EN62368 makes special mention of testing equipment with a special power supply sold with it for its exclusive use.
[edit: cross-posted with the above]

Also, to bookaboo's comment above: "Get a quote from your local test house, even if you don't get the testing done with them they will give you a list of the standards you need to comply with", our experience of this was that the test house expected us to know exactly which tests we wanted to carry out before they would quote - they were not at all interested in suggesting what we "should" be testing against. Your millage will probably vary.

Without wanting to hijack the thread, how normal/commonplace is it to hire a consultant to deal with this kind of stuff? We have also been struggling to negotiate conformance.

[pope]

So unless you go through thousands of pages or paying a little fortune there's no way to know what directives and standards should be applied right? I mean some kind of an EU online tool or free EU service that can give you a responsible answer. Lobbying at its best...

[Haenk]

Just an idea - I have seen (very) small series sold as "Prototype" units to commercial customers, maybe that is enough to skip EMI testings etc.
Another idea: Have the customer order a "built-to-order" custom product from you.

This is by no means a legal advice, and might be highly illegal. But maybe worth checking.

[Siwastaja]

Just an idea - I have seen (very) small series sold as "Prototype" units to commercial customers, maybe that is enough to skip EMI testings etc.

This is what everybody is doing all the time. If they are truly prototypes, there is no problem. This is not putting a product on market.

[pope]

I'm not a lawyer but i don't think that this is possible. As long as you sell something to somebody you're obliged to have it certified. At least this is my understanding.

And how can you sell "prototypes" on a website that has the product description, etc... I really don't think it's feasible.

[Siwastaja]

I'm not a lawyer but i don't think that this is possible. As long as you sell something to somebody you're obliged to have it certified. At least this is my understanding.

No. Prototypes do not require full compliance to standards and regulations, or CE marking. If they did, you could not prototype anything, thus you could not do compliance testing either and never have a product. It would be catch-22.

Further, it would be absurdly ridiculous to have a law dictating that prototyping must be done within one company and outsourcing any of it would be disallowed. Such law does not exist anywhere as I know. Prototypes almost always are noncompliant if evaluated by the rules required for product that is put on market. Only when you are ready to put the product on the market, then you need to (self-)certify and build documentation that shows compliance to relevant standards.

I'm not a lawyer either, but you are most certainly allowed to design, build and evaluate prototypes, and you are certainly allowed to outsource someone else to participate in that, so that money and goods are exchanged. Such prototypes or evaluation boards are even sold at Digikey etc., no problem.

Because there are not absolute and clear rules what is a prototype, there is a grey area. As usual, don't cause trouble to others and you'll be fine.

you're obliged to have it certified

Also this is not generally true, only in some specific fields such as mecidal. CE marking in most usual cases is self-certification. You can do it all by yourself if you so wish, and if you are truly confident you are doing the right thing and no once can find a flaw in your documentation and test procedures, it's all fine and legal.

You are probably confused because people often discuss if they can cheat by just calling something a "prototype" when it truly isn't. That's a different case.

[pope]

I'm not a lawyer but i don't think that this is possible. As long as you sell something to somebody you're obliged to have it certified. At least this is my understanding.

No. Prototypes do not require full compliance to standards and regulations, or CE marking. If they did, you could not prototype anything, thus you could not do compliance testing either and never have a product. It would be catch-22.

Further, it would be absurdly ridiculous to have a law dictating that prototyping must be done within one company and outsourcing any of it would be disallowed. Such law does not exist anywhere as I know. Prototypes almost always are noncompliant if evaluated by the rules required for product that is put on market. Only when you are ready to put the product on the market, then you need to (self-)certify and build documentation that shows compliance to relevant standards.

I'm not a lawyer either, but you are most certainly allowed to design, build and evaluate prototypes, and you are certainly allowed to outsource someone else to participate in that, so that money and goods are exchanged. Such prototypes or evaluation boards are even sold at Digikey etc., no problem.

Because there are not absolute and clear rules what is a prototype, there is a grey area. As usual, don't cause trouble to others and you'll be fine.

you're obliged to have it certified

Also this is not generally true, only in some specific fields such as mecidal. CE marking in most usual cases is self-certification. You can do it all by yourself if you so wish, and if you are truly confident you are doing the right thing and no once can find a flaw in your documentation and test procedures, it's all fine and legal.

You are probably confused because people often discuss if they can cheat by just calling something a "prototype" when it truly isn't. That's a different case.

Thanks.

I am aware of the fact that you can self-certify a product when a notified body isn't required. However I'm still struggling to see how can you sell a "prototype" to some individual (i.e not a company related to this industry) with all the legalities (VAT, etc.) and also how can you advertise it on your website.

[Siwastaja]

By just selling it. Like you would sell a bag of sand, exact details how to file taxes etc. vary by country.

You definitely can sell a bare PCB and a bag of components without requirement for CE marking, that's for certain.

Now some are pushing their luck by selling basically consumer products like single board computers that only need a case or one simple connector added. That is pushing your luck and probably beyond gray area. Many do that, too, and I'm personally satisfied they do, but this might indeed be illegal.

[jonpaul]

We have seen customs clearance of exports into EU, CA, DE, UK reject à shipment due to lack of certification of the contents.

anything like EMI, WEEE, ROHS, VAT, PFC ( Mains harmonics) safety compliance may be questioned by Countries and held until documents are provided.

Like any freight entering a Frontier via land, sea, air, the chance of examination is low but not zero.

The customer déclaration HT ECCN, (Harmonize) and declared value will affect the decision to examine or not.

If refused entry, The freight carrier will hold and return the shipment or customs,can destroy it.

Bon courage

Jon

[SiliconWizard]

Just an idea - I have seen (very) small series sold as "Prototype" units to commercial customers, maybe that is enough to skip EMI testings etc.

This is what everybody is doing all the time. If they are truly prototypes, there is no problem. This is not putting a product on market.

Yes.

Also, as I already said in other threads, unless your product falls into a specific, regulated category that requires going through a 'notified body', the company selling the product is the sole responsible for the CE mark. You could just sign the CE compliance declaration and never actually *do* any testing. It's all YOUR responsiblity, nobody's going to ask you to do any kind of testing until something goes wrong.

Just keep in mind that if you declare some product to be compliant with the relevant directives, this is YOUR responsibility. If you haven't done any formal testing, then declaring compliance is at best gambling, at worst a fraud (if said product appears not to be actually compliant.)

But not testing is not a fraud in itself. The fraud would be declaring something that isn't true. If you get the nuance.

What that means is that it's very frequent, especially for small companies and low-risk products, to actually never do any formal testing and write a CE declaration.
And it's not in itself a fraud. If you have no formal way of showing it's actually compliant, it's just very risky. This risk must be assessed in each particular case.

[Siwastaja]

But not testing is not a fraud in itself. The fraud would be declaring something that isn't true. If you get the nuance.

Yes. On the other hand, if the product is beyond "battery + resistor + LED" simplicity, EMC compliance testing tends to give ugly surprises. So not doing it is really pushing your luck because if your product causes some issues and if it's tested independently, risk of failing is pretty high.

LVD is much simpler, like buy decently rated certified components and keep 10mm (accounting for worst case standards that might apply) or so of distance between the mains and SELV. It's not black magic like EMC!

(In fact, I had my first mass market consumer product design (MCU, RS485, Ethernet, 2.45GHz radios, GPIO, analog, power relays, etc.) ever tested (have went the prototype way before due to specialized equipment and no consumer stuff) and everybody including the EMC lab said no one gets a first time EMC pass. And there it was, first time pass, without modifications to the prototype*. But that's because, as peter-h always reminds me, I'm an exceptional genius. Everybody else will obviously fail. )

*) but with modifications to wiring instructions. Gotta remember that ground wire for RS485, and use twisted pair.

[bookaboo]

Spending 10k-1M is not an option by any means as we're talking about a few units per year in a niche market. However I wouldn't call the product "cheap". Also, we are talking about an all analog device with a linear power supply so hopefully the EMC tests should be on the less complicated side (?). 

Just doing RED, EMC and LVD testing could easily cost all together 10KEUR . Though you might be able to find some local labs that could be cheaper than that. Then you have access to the Europen market.
What you need is really dependent on the product you make. For electronics, it's what others said. LVD, EMC, WEEE, RoHS. If it has a radio then you don't do EMC, you do RED.
Notice that these are not a single tests. The EMC directive covers dozens of standards that can be applied to your product based on what it is. A plush toy will have different EMC requirements than something that goes into an industrial environment. Once you identified which directive you need, you still have to figure out which standard to apply and in that standard, what level to use. Is it IEC 61000-4-4 level 1 or level 4? They have to setup the test differently in each case, and it's applicable to different equipment. So it's actually 3-4 levels down the rabbit hole you need to go.
Directive-> Standard -> levels in the standard. Often times multiple standards for the same directive.
You want to have a good idea what you need? Get a competing products "Declaration of Conformity". It's an A4 page that should list all these. It's not easy, and honestly, should be defined before you start a product, but the average manager is so clueless about how a project should be handled, I'm not even surprised anymore.

Unfortunately not the case, you have to do both EMC and RED for a product with radio functionality.

[pope]

To your specific case of a product with an external power supply, also of your design, I think you would want to handle this as a single product in two boxes. EN62368 makes special mention of testing equipment with a special power supply sold with it for its exclusive use.
[edit: cross-posted with the above]

Thanks, that's good to know. But what if the power supply has a different model name, different serial number and can be purchased separately? For example an external power supply might be able to power 10 units. So, buying the ps and as many units as you need is like buying two different products, right? I'm just thinking out loud really.

[Siwastaja]

You can always just define your product with DC inputs, and test it with generic DC lab supplies. Then your end customers can power it from car batteries, or buy any power supply, or you can sell power supplies like anyone would sell them; just resell supplies which are already legally imported in EU and have CE markings.

[switchabl]

So unless you go through thousands of pages or paying a little fortune there's no way to know what directives and standards should be applied right? I mean some kind of an EU online tool or free EU service that can give you a responsible answer. Lobbying at its best...

Figuring out the directives is usually not that hard, as was stated earlier, this page lists all CE directives (product groups): https://single-market-economy.ec.europa.eu/single-market/ce-marking/manufacturers_en
(and just to be clear, the small fortune you pay mostly for the actual testing and there is really no way around that)

I am assuming the electronic device you are building is not:
- a medical device
- part of a machine (moving parts)
- a toy
- used in explosive atmospheres
- a regulated measuring device (like an electricity meter)

Then you are left with:
- either EMCD and LVD or
 RED (if it has a radio transmitter/receiver)
- RoHS
- potentially Ecodesign (certain consumer/household equipment, list is here (Annex I) https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32008R1275)

From what you told us, you will probably end up with EMCD, LVD and RoHS. Now for the standards.
- Here is the list of all EMCD harmonised standards: https://ec.europa.eu/docsroom/documents/51314
The rule is to pick the most specific standard that applies to your product. There probably isn't one specifically for your niche product, so the most likely case is that you use one of the product family standards, like:
EN 55022/55024 Information technology equipment
EN 55032/55035 Multimedia equipment
EN 55103 Audio, video, audio-visual and entertainment lighting control apparatus for professional use
EN 61326 Electrical equipment for measurement, control and laboratory use
If none of the family standards apply, you would fall back to the generic EN 61000 standards. Note that the more specific standards refer to those in any case, they usually just contain additional information on how to apply them (test setups, what limits to test to and so on).
- Now for LVD: https://ec.europa.eu/docsroom/documents/53895
This list is annoyingly long, fortunately most of it is cables, electrical installation material and houeshold appliances. Again, a lot of products will use product family standards, in particular:
EN 60950 Information technology equipment
EN 61010 Electrical equipment for measurement, control, and laboratory use
EN 62368 Audio/video, information and communication technology equipment
- RoHS is essentially about collecting the right paperwork on your suppliers and components. There is currently only one harmonised standard, EN IEC 63000:2018.

Unfortunately not the case, you have to do both EMC and RED for a product with radio functionality.

You are both right (kind of). The EMC and LV directives do not apply to radio products but the RED includes most of the requirements from both. So only RED appears on the declaration of conformity, however you still need to do all the tests.

On the topic of "creative loopholes" I will just say that EU regulators are not stupid. Case in point, this is the actual wording in the LVD on the declaration of confirmity:
"The EU declaration of conformity shall state that the fulfilment of the safety objectives referred to in Article 3 and set out in Annex I has been demonstrated." (emphasis mine) You are also required to create and keep technical documentation on this and may be asked to produce it later on (though usually only if something goes wrong). The LVD also does not mention the word "prototype", the question is rather whether the product has been "placed on the market" (which is usually not the case for a genuine prototype). So in any case, take legal advice from random guys on the internet with just a tiny grain of salt...