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European CE certification nonsense

AgnewBlues

Plastic
Joined
Nov 14, 2021
I have recently been told that one interpretation of the current EU regulations regarding CE certification requires machine shops to certify the parts they make, to comply. That is, if your shop is either located in the EU, or anywhere else in the world if you would need to send parts to the eu.

This was news to me. Has anybody here had to deal with this? Either based in the EU, or sending parts there? Ever had issues sending parts to Europe?

I thought that OEMs had to certify their product, but it seems that the individual parts that make up the product also need to be certified, by whoever is producing them. Non-certified parts that would normally need to be certified run the risk of not being allowed into the EU.

Same applies to old iron being imported, as well as measurement instruments and so on.

I wonder how others are dealing with this, especially when it comes to small runs, prototypes, or one off parts.


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How do you define "certified"?

Depends on the product. Certain things need to be certified by certain authorities, but simple things like plain metal parts can be self certified by whoever makes them. Printing out and sticking on the CE mark is the simple part of the exercise. When using the CE Mark, you are legally obliged to maintain a file for each product with the results of the required tests that you were meant to have conducted, a full description of the product, complete CAD drawings, a declaration of conformity signed and dated by the relevant inspector in your company, and so on. This implies that you will have researched and fully understood all the legal requirements, depending on the intended use of the part. If it is pressure vessel parts or hydraulic system parts, or structural parts that will be used for building a bridge, it can quickly get ridiculously complicated. It seems highly unrealistic for one off parts for service work etc.


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There was a "*" adjacent to the CE, and at the bottom of the bottle, it stated "* applies to thoroughly washed container with no contents".
I thought at the time, that's a waste of ink!

Chemicals are exempt, but the containers they are sold in are not!

Indeed, a waste of ink!


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CE is Europe's equivalent to the US's UL except more strict. Its purpose is to protect the public from dangerous products and scams. It applies to all goods sold to the general public. The legal responsibility of certification responds to the importer, not the manufacturer. The CE label only states that there is one or more ISO standards that the product is in compliance of. If the purchaser wishes to know just what standards the product complies to, he must request a copy of the compliance tests. It is also important to note that a CE label is authorized to display if only one of perhaps many ISO standards that are applicable.
 
The CE scam isn’t worth its ink. I have worked with a company that prides itself in fully complying with ISO 9001 and other standards but the certification chain is ruptured right at the beginning where I can forge figures on the first paper written. The mate who notes the material number was also free to exchange bars without that I would have sensed. So parts would possibly be turned from 1.4301 instead of 1.4404. The control doesn’t work. And don’t think anyone would have made a stock test on the first part I handed in. Not even put on scales. The bureau people never leave the bureau.
 
In fact the purpose of CE was to lock foreign manufactures out of the EU ,without running foul of WTO agreements ,which may have caused retaliatory actions......like Trumps tariffs.
 
The legal responsibility of certification responds to the importer, not the manufacturer.

If a product doesn’t already have the CE Mark when being imported, then the importer has to pay for the procedure of acquiring the certification, otherwise the goods will be stuck at customs.

But, this only applies to goods that are actually being imported. If the goods are manufactured inside Europe, then there is no importer. It is the manufacturer that needs to take care of certification.

I have been looking into this and it does not appear that there is any exemption for component parts, contract manufacturing, bespoke products, prototypes, or one off parts. Even custom machinery built exclusively for the manufacturers own use, need to be certified.

If goods are being imported, there is a definite check at customs. But if the goods are made inside Europe, I’m not sure how often things are really checked.


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In fact the purpose of CE was to lock foreign manufactures out of the EU ,without running foul of WTO agreements ,which may have caused retaliatory actions......like Trumps tariffs.

Sorry John,
That's not true. There are sufficient examples of unsafe products being imported and sold within the EU, just as there are everywhere else in the world, especially from 3rd world countries. There are a host of other regulations that protect the end consumer like a mandatory 2 year guarantee in Germany. These rules do not apply to B to B acquisitions. The biggest problem with the CE program is its selective enforcement.
 
These rules do not apply to B to B acquisitions. The biggest problem with the CE program is its selective enforcement.

CE certification still applies for B to B acquisitions. Selective enforcement aside, the biggest problem I see with the CE regulations is the requirement for ridiculous amounts of bureaucracy even for a small low value part for service work. If you try to comply, it will push up the price of the part to the point where it will not be viable for the customer to actually repair the equipment the part was intended for.

It also hinders sectors that depend on custom equipment, and small runs of parts.

This makes it impossible for such sectors in Europe to be competitive internationally, compared to countries without the requirement for excessive bureaucracy around single parts.

Safe products are good, but there are much more reasonable ways to achieve that. The CE regulations were obviously designed by politicians who have never worked in a real job in their life.


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Holy shit. You guys have seriously no idea what the CE mark is and what it stands for.
EDIT: That was a stupid way to start a post, I apologize.

I work with CE marking in europe and it's not that complicated as some of you make it out to be.

Let me clear up some misunderstandings:
1. The CE marking SHOULD NOT be placed on goods that is not on the list of goods that require CE marking. The list of goods that do can be found all over the web, but this is one of them: CE marking - GOV.UK

2. A CE marked product HAVE NOTHING to do with ISO standards. Nowhere in any of the requirements is there any mention of applicable standards whatsoever. But a harmonized standard CAN be used to make your life easier as a designer, as you know that the standard already have taken the CE requirements into consideration. A standard is not mandatory, and never will be.

3. Different goods have different requirements to be met, and which requirements that is can always be found, free of charge, on the web. This for example is of machinery: EUR-Lex - 32006L0042 - EN - EUR-Lex
I suspect that most of you will use that one as a producer of parts. But before you go rampant about all the millions of pages, read no. 4.

4. I do not work with chemicals or most of the other things that should carry a CE marking, I almost exclusivly work with machinery. So this following is regarding machines, I do not know if it's also applicable to other areas.
If you read the definition of machine, you find that it is required to have moving parts powered by something other than direct manual energy. If your device has a manual crank handle and a 2:1 reduction, it's a machine. If it has no reduction, it is not. If it's not a machine, it SHOULD NOT HAVE A CE MARKING that refers to machinery directive.
Quite simple. Now, there are a lot of machines that are not covered by that directive and falls under a different one. It's all listed in the beginning of the document.

5. CE marking is, in most instances, something you do yourself as a manufacturer or importer. No 3rd party is required most of the time, but some machines will need a inspection from 3rd party because they are considered too dangerous. These machines are listed aswell in the document. Don't spend thousands of cash for some consultant, RTFM.

6. Most of you that only make parts will NEVER have to deal with CE marking. Ever.
To be honest I have never heard such utter bullshit as a CE-required part coming off a CNC mill/lathe.

CE marking is all about safety and reliability. For example, directive might state that you should not be able to chop your limbs off in a machine. A harmonized standard will say that you should have xxx mm of space between moving parts. Thats the difference between the directive and standards. But the standards are not mandatory. In any way.
But if an accident happens you as importer/mfg will have to prove that your machine is safe and fullfills the directive requirements. A standard does that. Not following a standard places all that responsibility with you.

But most of all, do not put a CE mark on something that should not have it. It's technically an offence.

EDIT no 2: I just went through all of my chemical containers for soap, acetone and the like I have at home. None hade a CE mark, and I serously doubt that they are required to have one. Because if the container have a CE mark it will also need a what is called "Declaration of conformity", which declares that the product meets the CE requirements and more importantly which one. I have never seen such a document in any grocary store.

So if you really found a CE mark on one of those containers that CE mark is illegal, and probably the company that put it there had no idea what the fuck they where doing.
That is actually the problem, people put CE marks on everything and it gives CE mark a bad reputation. If you're interested in a product that have a CE mark. demand to get the DoC document so you can see what directive it actually refers to. Otherwise it is illigal.
 
Ah, that explains it!
A bubble-blowing-device is probably considered a toy.
Toys are regulated and have their own directive.

But yeah sure mate, you don't need to be ashamed! We all like to blow
bubbles from time to time :D
 
The main goal of CE was to equalize all regulations within Europe so importing and exporting to different countries was way way easier
Also the UK Norway Iceland and with some products Switserland and Turkey comply More to follow??

Also be aware of the chinese CE which is slightly different and means Chinese Export :scratchchin:
No Conformité Européenne
https://radio2.be/sites/default/files/components-images/2019-10/FakeCEmark_0.png

Peter
 
Good point!

Well UK might be out of the picture soon, they have their own UKCA marking as of 2022.
But for now it follows the eu directives afaik, and will probably do so for the forseable future. However they require their UKCA marking along with CE mark if the product will be put on their market.

This has put some gravel in my gears since we produce a lot of lifting and assembly equipment that will be used during assembly of the new HVDC powerstations in the uk. Nobody really knows how to handle this since they are tools that the assembly teams brings with them from EU. Should they conform with UK standards or not..?
We made life easy by just doing the UKCA anyway to be on the safe side.
 
If something is produced in sufficient quantity, it is not much of an issue to certify. The problem is more with products that are not produced in quantity.


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Holy shit. You guys have seriously no idea what the CE mark is and what it stands for.
EDIT: That was a stupid way to start a post, I apologize.

I work with CE marking in europe and it's not that complicated as some of you make it out to be.

Let me clear up some misunderstandings:
1. The CE marking SHOULD NOT be placed on goods that is not on the list of goods that require CE marking. The list of goods that do can be found all over the web, but this is one of them: CE marking - GOV.UK

2. A CE marked product HAVE NOTHING to do with ISO standards. Nowhere in any of the requirements is there any mention of applicable standards whatsoever. But a harmonized standard CAN be used to make your life easier as a designer, as you know that the standard already have taken the CE requirements into consideration. A standard is not mandatory, and never will be.

3. Different goods have different requirements to be met, and which requirements that is can always be found, free of charge, on the web. This for example is of machinery: EUR-Lex - 32006L0042 - EN - EUR-Lex
I suspect that most of you will use that one as a producer of parts. But before you go rampant about all the millions of pages, read no. 4.

4. I do not work with chemicals or most of the other things that should carry a CE marking, I almost exclusivly work with machinery. So this following is regarding machines, I do not know if it's also applicable to other areas.
If you read the definition of machine, you find that it is required to have moving parts powered by something other than direct manual energy. If your device has a manual crank handle and a 2:1 reduction, it's a machine. If it has no reduction, it is not. If it's not a machine, it SHOULD NOT HAVE A CE MARKING that refers to machinery directive.
Quite simple. Now, there are a lot of machines that are not covered by that directive and falls under a different one. It's all listed in the beginning of the document.

5. CE marking is, in most instances, something you do yourself as a manufacturer or importer. No 3rd party is required most of the time, but some machines will need a inspection from 3rd party because they are considered too dangerous. These machines are listed aswell in the document. Don't spend thousands of cash for some consultant, RTFM.

6. Most of you that only make parts will NEVER have to deal with CE marking. Ever.
To be honest I have never heard such utter bullshit as a CE-required part coming off a CNC mill/lathe.

CE marking is all about safety and reliability. For example, directive might state that you should not be able to chop your limbs off in a machine. A harmonized standard will say that you should have xxx mm of space between moving parts. Thats the difference between the directive and standards. But the standards are not mandatory. In any way.
But if an accident happens you as importer/mfg will have to prove that your machine is safe and fullfills the directive requirements. A standard does that. Not following a standard places all that responsibility with you.

But most of all, do not put a CE mark on something that should not have it. It's technically an offence.

EDIT no 2: I just went through all of my chemical containers for soap, acetone and the like I have at home. None hade a CE mark, and I serously doubt that they are required to have one. Because if the container have a CE mark it will also need a what is called "Declaration of conformity", which declares that the product meets the CE requirements and more importantly which one. I have never seen such a document in any grocary store.

So if you really found a CE mark on one of those containers that CE mark is illegal, and probably the company that put it there had no idea what the fuck they where doing.
That is actually the problem, people put CE marks on everything and it gives CE mark a bad reputation. If you're interested in a product that have a CE mark. demand to get the DoC document so you can see what directive it actually refers to. Otherwise it is illigal.

Thank you for taking the time to post in such detail. I have been looking through these documents trying to make sense of them. Technically, parts of machinery do not fulfill the definition of machinery for the purposes of the EU directive, so they should be exempt from requiring certification.

In practice, I am having a dispute with certain officials currently, regarding exactly this issue. Their interpretation is that parts that will be used in machinery which falls under the machinery directive, need to be certified as well, unless they are provided by the original manufacturer of the equipment and have already undergone certification together with the rest of the product.

It is explicitly stated in the directive that parts provided by the original manufacturer are exempt. It is not stated explicitly that parts made by third parties are also exempt. However, I would think that they fall outside the scope of the directive, as they fail to meet the definition of machinery as stated in the document.

The even more murky area is assemblies of several parts. Not a complete machine, but a complex assembly that is designed to be used on a machine.

I have also never encountered CE marking on individual machined parts, but some in a position to get me in trouble seem to have a different opinion on the matter.

There is a construction materials directive. Does raw stock need to be certified? It certainly doesn’t come with stickers!

From what point onwards does the product of a machine shop need to be certified? Only if it is a complete machine? And how about repair work, where a machine is extensively modified? Who is then burdened with certification? The machine shop or the customer?


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The CE mark is only required on the finished product- not on individual custom parts that make up the product. It is the responsibility of the product manufacturer- not the shop making the part to comply with any regulatory approvals required for components. The compliance is normally checked during factory inspections conducted by the agency that certified the product. An agency example is TUV or UL. Shops are normally required only to certify that the parts they are making conform to the part print and or specifications. This is an issue between the shop and the customer- not between the shop and the country of import. The manufacturer of the product usually issues a Declaration of Conformity that states the product is compliant to EU requirements.
 
...The compliance is normally checked during factory inspections conducted by the agency that certified the product. An agency example is TUV or UL...

Not to be picky but yes and no.
Unless the machine is considered a dangerous machine there are no agency that need to certify the product. Then but only then is the product required to be certified by a notified body as we call it over here in the EU. But sure, a notified body will probably assist you if you ask for it (and pay for it).
 
Thank you for taking the time to post in such detail. I have been looking through these documents trying to make sense of them. Technically, parts of machinery do not fulfill the definition of machinery for the purposes of the EU directive, so they should be exempt from requiring certification.

In practice, I am having a dispute with certain officials currently, regarding exactly this issue. Their interpretation is that parts that will be used in machinery which falls under the machinery directive, need to be certified as well, unless they are provided by the original manufacturer of the equipment and have already undergone certification together with the rest of the product.

It is explicitly stated in the directive that parts provided by the original manufacturer are exempt. It is not stated explicitly that parts made by third parties are also exempt. However, I would think that they fall outside the scope of the directive, as they fail to meet the definition of machinery as stated in the document.

The even more murky area is assemblies of several parts. Not a complete machine, but a complex assembly that is designed to be used on a machine.

I have also never encountered CE marking on individual machined parts, but some in a position to get me in trouble seem to have a different opinion on the matter.

There is a construction materials directive. Does raw stock need to be certified? It certainly doesn’t come with stickers!

From what point onwards does the product of a machine shop need to be certified? Only if it is a complete machine? And how about repair work, where a machine is extensively modified? Who is then burdened with certification? The machine shop or the customer?

No problem, here to help!

I will try to answer your questions as best I can. This might be a long one...

Let's begin:

As with any kind of "law-like" text, there are several cases that might be considered a gray area. But also as with any law, if it's not stated that it's forbidden, well...

But one thing is important. The directives all states that the product should be safe, so whatever you do make sure it is and most importantly, that you can prove it. It might be with calculations that prove it should be able to carry the load with the stated safety factor, risk assessments, probable misuse of the product etc.
A manual that shows how the product should be used along with at least some text that explicitly forbid foreseeable misuse is a good start to say the least.

On to some meat:

This is the machinery directive in direct pdf form in english, and sources below can be found in this directive: https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2006:157:0024:0086:EN:PDF

Machine is a assembly with at least one moving part that have or is intended to have a power source other than direct human or animal effort.
Also, lifting equipment such as hoists are considered machines even though they have direct human input.
(Article 2, section "a")

What this means is that if you make a "machine" that is not used for lifting, and does not have any external power source, and importantly does not have any reduction
from the human input (lets say a table with fixed height on wheels that you can push around), it is not considered a machine.
If however the table has some kind of crank with a gear reduction or the like, it is not direct input anymore and is to be considered a machine.
That is important to keep in mind.

Now, about parts of machinery.
The directive have a section that describes what is called 'partly completed machinery'. These also falls under the machinery directive, that is true. But, the definition of a partly completed machine is that it should be made of assembled parts that in themselves cannot function as a machine.
(Article 2, section "g")

So it is quite clear if you only make one part, replacement or not for any machine, it will not be considered a machine or partly completed machine.
That's it. NO CE mark applies here, and none should be put on the part!

EDIT: I need to clarify something here: A part that changes an existing machine's function is considered "interchangeable equipment". See Article 2 section "b".

However, you also had some questions about assemblies of parts, which unfortunately falls under the partly completed machine category.
This is more or less the same as a "full blown" CE marking, which in principle it is. But fear not!

(Oh and btw, it's fully legal to make parts or partly completed machinery that incorporates into other manufacturers machines. See Article 6 section "2".
But you probably will void the warranty if any)

It is not too complicated to produce a CE marked machine. Remember that it is all about safety. In essence follow these steps:

1) If the machine is not listed in Annex IV (also called a dangerous machine) you will use your own internal assessment (Article 12).
That means that you as a manufacturer (or importer) can put the CE mark on your product by yourself, after the assessment.

2) Article 12, section 2 refers to this by transferring you to Annex VIII, which in turn is three small sections. Read it if you want, but the meaty part is that Annex VIII refers to Annex VII, which is the important part of this. A lot of jumping around but I can summarize Annex VIII for you:
A) Do Annex VII
B) Make sure you still fulfill Annex VII if serial production
C) Profit $$$$

3) Annex VII states what assessment you have to do. Let me summarize it for you:

A) Is the machine safe? Make a risk assessment (and include probable misuse!). It does not need to be a trillion pages, most of our "simpler" machines only have one A4 page, and it's not filled to the brim. In this risk assessment, state how you solve the risks that need to be solved. In sweden we consider any accident that will make you get a blue nail or worse to be taken into consideration and the risk reduced or eliminated. Save this risk assessment page somehow, does not need to be a physical copy.

B) Is the machine able to do what it should be doing without overloading any components? This might be a bit tricky if you do not have any calculation software or suck at math. But actually in that case, you can go russian style and just smack more meat to the part until anyone can see that it will not fail in a million years.
(This is an unofficial tip, it did not come from me if anyone asks: If you are fucki'n sure that the part will not fail and it is not a safety component, just ignore it. If this part breaks down in a dangerous way and the investigator wants to see your documentation for this very part, you can make the calculations at a later date. No it is not illegal, Annex VII section "2" part "2" clearly states that you will have to be able to show this in a period of time if someone asks. Read that section, quite interesting..).

C) If A and B is good, time to make your machine. After you have made it, save the drawings.
We (in "my" company) creates everything in Inventor, including notes and the like. Then we just save the parts and the assemblies as a .STEP file in AP242 format to get the notes etc. into the file. Easy-peasy.

D) After the machine is made and you have tried that everything works as it should and the machine is safe as expected, you might take some pictures. Preferably with load on the machine. If you have an assembly checklist, save it. If not, no biggie..

E) Make a user manual. THIS IS THE IMPORTANT BIT!
Most if not all accidents happens because of deficient instructions.
1. Make sure that you describe how the machine should be used, or a partly completed machine should be assembled.
2. Explicitly state how it should not be used (remember the risk assessment with foreseeable misuse?).
2. How it should be cleaned. ("No aggressive detergents" as an example).
3. Other technical data (length, height, width, weight, max load etc.. etc..).

4.1. If it's a partly completed machine: Search for Annex II, section "2". This dictates how the DoC document should look like. Also search on the internet for examples, it's much easier to see. A partly completed machine has a different DoC document that a fully completed machine, thats more or less the difference between the two.

4.2. If it's a fully completed machine: Search for Annex II, section "1". If you followed any standard you should state it in this document, as well as what directive your machine applies to. You can look at examples of this document on the internet. Search for "Declaration of conformity".

F) When you're done with the above, smack that CE mark on the machine and push it through the door! Include a copy of the manual attached to the machine at delivery.

DONE!!

The above might be somewhat simplified. The mfg date, the mfg company etc. should be on the machine ID plate along with serial number and so on. But if you make a machine you're probably intelligent enough to get that. :D

To be noted, safety components is somewhat more complex and I would personally advice not to go there since it actually might put someone in danger.
This refers to if you're replacing a safety component on someone else's machine obviously.
Article 2 section "c" is related to safety components and feel free to read it.


On to the next question about materials:
"Construction Materials Directive" is no more, it has been superseded by Regulation 305/2011, also called "Construction Product Regulation".
But to answer your question: NO. The material you use in your machine/product does not need to be certified according to CPR directive.

The directive is targeted at the manufacturers of building materials, especially relating to safety in case of fire, mechanical properties etc.
Nothing you need to worry about unless you make big-ass lego blocks to build houses from.


When does it need to be certified?
When released to the market or putting into service (that includes if you produce it for yourself).
You cannot sell or give any machine to anyone in the EU if it's not CE marked (but should be). Never. Ever.
You can not use any machine that is not CE marked (but should be). Never. Ever. (In a company that is, as a civilian there are almost no rules)
There can be hefty fines for this.
The reason is that if someone uses your machine in your shop they should not risk being injured. Never. Ever.
There are some exceptions of course, regarding for example old machinery etc. But even old machinery need to be equipped with some basic safety equipment to be allowed to use.

About modification of existing machine
If you produced the machine yourself you need to update your documentation to incorporate the changes.
If someone else made the machine, well.. Here lies a problem.

Technically you can not do anything to someone else's machine without voiding their CE marking. If you drill a hole? No can do. If you paint it with/in different color? Nope nope nope...
Their CE marking is void after that, and the owner of the machine is responsible for the CE marking. In other words, the owner will be fined.
Now, if you get a real nazi to notice that knows the machine and is a piece of shit he can cause trouble.
In the real world though, not a big problem unless you actually compromise the machine safety or reliability.

However, Pro-tip! If the machine is not inherently unstable or the like, you can actually clamp stuff to a machine. That is more or less a funny loop-hole since you do not compromise the integrity of the machine in any way. That is okay as long as their manual does not explicitly forbid it, and that is rare. Remember the foreseeable misuse part? :D

That's it I think...
 
No problem, here to help!

I will try to answer your questions as best I can. This might be a long one...

Let's begin:

As with any kind of "law-like" text, there are several cases that might be considered a gray area. But also as with any law, if it's not stated that it's forbidden, well...

But one thing is important. The directives all states that the product should be safe, so whatever you do make sure it is and most importantly, that you can prove it. It might be with calculations that prove it should be able to carry the load with the stated safety factor, risk assessments, probable misuse of the product etc.
A manual that shows how the product should be used along with at least some text that explicitly forbid foreseeable misuse is a good start to say the least.

On to some meat:

This is the machinery directive in direct pdf form in english, and sources below can be found in this directive: https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2006:157:0024:0086:EN:PDF

Machine is a assembly with at least one moving part that have or is intended to have a power source other than direct human or animal effort.
Also, lifting equipment such as hoists are considered machines even though they have direct human input.
(Article 2, section "a")

What this means is that if you make a "machine" that is not used for lifting, and does not have any external power source, and importantly does not have any reduction
from the human input (lets say a table with fixed height on wheels that you can push around), it is not considered a machine.
If however the table has some kind of crank with a gear reduction or the like, it is not direct input anymore and is to be considered a machine.
That is important to keep in mind.

Now, about parts of machinery.
The directive have a section that describes what is called 'partly completed machinery'. These also falls under the machinery directive, that is true. But, the definition of a partly completed machine is that it should be made of assembled parts that in themselves cannot function as a machine.
(Article 2, section "g")

So it is quite clear if you only make one part, replacement or not for any machine, it will not be considered a machine or partly completed machine.
That's it. NO CE mark applies here, and none should be put on the part!

EDIT: I need to clarify something here: A part that changes an existing machine's function is considered "interchangeable equipment". See Article 2 section "b".

However, you also had some questions about assemblies of parts, which unfortunately falls under the partly completed machine category.
This is more or less the same as a "full blown" CE marking, which in principle it is. But fear not!

(Oh and btw, it's fully legal to make parts or partly completed machinery that incorporates into other manufacturers machines. See Article 6 section "2".
But you probably will void the warranty if any)

It is not too complicated to produce a CE marked machine. Remember that it is all about safety. In essence follow these steps:

1) If the machine is not listed in Annex IV (also called a dangerous machine) you will use your own internal assessment (Article 12).
That means that you as a manufacturer (or importer) can put the CE mark on your product by yourself, after the assessment.

2) Article 12, section 2 refers to this by transferring you to Annex VIII, which in turn is three small sections. Read it if you want, but the meaty part is that Annex VIII refers to Annex VII, which is the important part of this. A lot of jumping around but I can summarize Annex VIII for you:
A) Do Annex VII
B) Make sure you still fulfill Annex VII if serial production
C) Profit $$$$

3) Annex VII states what assessment you have to do. Let me summarize it for you:

A) Is the machine safe? Make a risk assessment (and include probable misuse!). It does not need to be a trillion pages, most of our "simpler" machines only have one A4 page, and it's not filled to the brim. In this risk assessment, state how you solve the risks that need to be solved. In sweden we consider any accident that will make you get a blue nail or worse to be taken into consideration and the risk reduced or eliminated. Save this risk assessment page somehow, does not need to be a physical copy.

B) Is the machine able to do what it should be doing without overloading any components? This might be a bit tricky if you do not have any calculation software or suck at math. But actually in that case, you can go russian style and just smack more meat to the part until anyone can see that it will not fail in a million years.
(This is an unofficial tip, it did not come from me if anyone asks: If you are fucki'n sure that the part will not fail and it is not a safety component, just ignore it. If this part breaks down in a dangerous way and the investigator wants to see your documentation for this very part, you can make the calculations at a later date. No it is not illegal, Annex VII section "2" part "2" clearly states that you will have to be able to show this in a period of time if someone asks. Read that section, quite interesting..).

C) If A and B is good, time to make your machine. After you have made it, save the drawings.
We (in "my" company) creates everything in Inventor, including notes and the like. Then we just save the parts and the assemblies as a .STEP file in AP242 format to get the notes etc. into the file. Easy-peasy.

D) After the machine is made and you have tried that everything works as it should and the machine is safe as expected, you might take some pictures. Preferably with load on the machine. If you have an assembly checklist, save it. If not, no biggie..

E) Make a user manual. THIS IS THE IMPORTANT BIT!
Most if not all accidents happens because of deficient instructions.
1. Make sure that you describe how the machine should be used, or a partly completed machine should be assembled.
2. Explicitly state how it should not be used (remember the risk assessment with foreseeable misuse?).
2. How it should be cleaned. ("No aggressive detergents" as an example).
3. Other technical data (length, height, width, weight, max load etc.. etc..).

4.1. If it's a partly completed machine: Search for Annex II, section "2". This dictates how the DoC document should look like. Also search on the internet for examples, it's much easier to see. A partly completed machine has a different DoC document that a fully completed machine, thats more or less the difference between the two.

4.2. If it's a fully completed machine: Search for Annex II, section "1". If you followed any standard you should state it in this document, as well as what directive your machine applies to. You can look at examples of this document on the internet. Search for "Declaration of conformity".

F) When you're done with the above, smack that CE mark on the machine and push it through the door! Include a copy of the manual attached to the machine at delivery.

DONE!!

The above might be somewhat simplified. The mfg date, the mfg company etc. should be on the machine ID plate along with serial number and so on. But if you make a machine you're probably intelligent enough to get that. :D

To be noted, safety components is somewhat more complex and I would personally advice not to go there since it actually might put someone in danger.
This refers to if you're replacing a safety component on someone else's machine obviously.
Article 2 section "c" is related to safety components and feel free to read it.


On to the next question about materials:
"Construction Materials Directive" is no more, it has been superseded by Regulation 305/2011, also called "Construction Product Regulation".
But to answer your question: NO. The material you use in your machine/product does not need to be certified according to CPR directive.

The directive is targeted at the manufacturers of building materials, especially relating to safety in case of fire, mechanical properties etc.
Nothing you need to worry about unless you make big-ass lego blocks to build houses from.


When does it need to be certified?
When released to the market or putting into service (that includes if you produce it for yourself).
You cannot sell or give any machine to anyone in the EU if it's not CE marked (but should be). Never. Ever.
You can not use any machine that is not CE marked (but should be). Never. Ever. (In a company that is, as a civilian there are almost no rules)
There can be hefty fines for this.
The reason is that if someone uses your machine in your shop they should not risk being injured. Never. Ever.
There are some exceptions of course, regarding for example old machinery etc. But even old machinery need to be equipped with some basic safety equipment to be allowed to use.

About modification of existing machine
If you produced the machine yourself you need to update your documentation to incorporate the changes.
If someone else made the machine, well.. Here lies a problem.

Technically you can not do anything to someone else's machine without voiding their CE marking. If you drill a hole? No can do. If you paint it with/in different color? Nope nope nope...
Their CE marking is void after that, and the owner of the machine is responsible for the CE marking. In other words, the owner will be fined.
Now, if you get a real nazi to notice that knows the machine and is a piece of shit he can cause trouble.
In the real world though, not a big problem unless you actually compromise the machine safety or reliability.

However, Pro-tip! If the machine is not inherently unstable or the like, you can actually clamp stuff to a machine. That is more or less a funny loop-hole since you do not compromise the integrity of the machine in any way. That is okay as long as their manual does not explicitly forbid it, and that is rare. Remember the foreseeable misuse part? :D

That's it I think...

Thank you so much for this detailed post! That explains a lot of the confusing stuff. Excellent tips! Two questions remaining however:

When it comes to assemblies of several parts, falling within the scope of the machinery directive, if it is just a prototype for a customer, which I will never make again most likely, who is responsible for CE marking? Me or the customer? I do make a lot of assemblies that will presumably be used with another machine, sometimes made to prints and instructions provided by the customer. Other times I am asked to also design the assembly for a particular application, and make it. Most often the PO specifies that the assembly must be delivered assembled and tested. I have never had anyone request that their assembly must be delivered with CE marking.

I guess if I could provide the parts in boxes, for the customer to assemble, it would no longer fall within the scope of the machinery directive at my end. But I guess completed assemblies do? Unless it is claimed that the assemblies are exclusively intended for research purposes and will be used temporarily in a laboratory setting..?

Does the CE marking requirement still apply to one-off goods (assemblies) that are made in the EU for export to a non-EU country that does not use the CE scheme? As in an order from a customer in a non-EU country?

This is quite often the case actually, and I am worried that if I have to CE certify all my prototype assemblies, even the ones not intended for the EU market, the cost and liability would render me highly uncompetitive in pricing, compared to shops in countries where there are no such requirements.
 








 
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