Is CE marking required when a single unit will be manufactured?

[Just_another_Dave]

Hello everyone:

We have built a prototype of a measurement equipment for in house use and after some successful tests it seems that our company is interested in using it, so they’re considering designing a more robust version that could be used in production. However, the safety department has said that CE marking might be required (they can’t ensure it). Although it would be possible to test it internally, it will increase significantly the amount of time required to deliver it, as well as the cost of the project. However, it seems reasonable to expect regulation to have exceptions for custom equipment that will just be used internally when a single unit will be manufactured

The product will be designed taking into account regulations, but delaying certifications would reduce the amount of work that we’ll need to complete in the short time

Do you know if there’s any exception applicable for this case? Do you normally conduct certifications required for CE marking equipment that will be used internally (never sold)?

[Siwastaja]

Compliance (and thus, marking) is required if the product is placed on the market. Tool for internal use is not placing anything on market.

There are no "exceptions" on the regulation for cases like this because the whole regulation does not apply at all; the premise is completely on the placing on market part.

The tool of course needs to be safe; normal laws that protect workers apply.

But beware. If you are distributing the tool more widely, even free-of-cost, it can be though as equivalent to placing on the market, because asking money for it is not a strict condition. How placing on the market is exactly defined is difficult and there is a large grey area, although on EEVblog forum you will find armchair experts who are sure that even farting requires CE marking because they can find random out of context excerpts on some random documents.

The most common mistake is to desperately trying to find "exception" from a document which does not apply at all.

But if you are truly sure you are not placing anything on a market, not even close, then rest assured there is nothing to worry about. Then again if you are just saying so trying to find loopholes, it's difficult - the loopholes are well plugged.

[showman]

Compliance (and thus, marking) is required if the product is placed on the market. Tool for internal use is not placing anything on market.

First of all, I for sure don't know the answer, but https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.C_.2022.247.01.0001.01.ENG says among many other things that

Some Union harmonisation legislation covers also ‘putting into service’(e.g. lifts) or ‘own use’ (e.g. machinery to be used by the manufacturer himself) as being equivalent to the ‘placing on the market’

and that

Placing on the market is considered not to take place where a product is manufactured for one’s own use unless Union harmonisation legislation covers products manufactured for own use in its scope (See for instance, the Directives on Machinery, Measuring Instruments, ATEX, Civil Explosives.)

[Siwastaja]

Yeah, so it gets nasty, you need to dive into details what types of measuring instruments have extended coverage into own use.

It is easy to guess why this is so (from the mention of lifts specifically). Obviously the instruments need to be safe.

[Just_another_Dave]

Thanks for your answers. We’ll need to check it, but that line saying that measuring instruments require CE marking even if it’s for your own use sounds really bad. Probably we’ll have to conduct those tests

[Siwastaja]

that line saying that measuring instruments require CE marking even if it’s for your own use

It doesn't say so, it says directives on measuring instruments have scope on own use. You have to find the relevant standards and look exactly what they say about own use. It will be an explicit exception to the generic rule that own use is not placing on the market.

Bad news in a sense that you need someone who has expertise and time to read and understand what the standards / directives say. Which is large part of the work anyway. But I would guess it is safety related. Like, if EMC was required then surely it wouldn't be limited to measuring instruments only. So expect to see a more lightweight process, but process nevertheless.

[SiliconWizard]

Thanks for your answers. We’ll need to check it, but that line saying that measuring instruments require CE marking even if it’s for your own use sounds really bad. Probably we’ll have to conduct those tests

First read it and see if it applies.

Second, unless your company operates in a regulated field (meaning you can't self-certify), then CE marking is a self-certification. So, check that first.

If you can self-certify, you don't actually *have* to conduct anything apart from writing a declaration of conformity and having it signed by your CEO, or QA director if you have one. Of course, they may not be willing to sign it if you don't have collected (through documentation and testing) enough evidence about conformity, but testing in itself is not a legal requirement.

[dmendesf]

I know you're talking about CE (europe), not USA (fcc), but seems at at least USA got some sane rules that dev kits for RF devices don't need FCC certification, even if sold. They just can't be resold in the open market. So you can buy a BLE evaluation kit at digikey that has no FCC certification but you cannot just strap some circuit on it, put in a box and sell as a product. Seems fair.

[Salitronic]

Equipment that falls under specific directives, such as Machinery, ATEX, Pressure Equipment, LVD, Lifts, Radio Equipment, and others, typically requires CE marking, even if it's for in-house use. Although with CE being self-declared, the extent to which this is actually verified for a one-off in-house equipment is debatable.  It's important to differentiate between internal use as a development prototype and equipment that is operational on an in-house shop floor. Employees and operators using the equipment are effectively third parties and should be able to trust that any equipment they use is appropriately safety certified.

[Just_another_Dave]

Equipment that falls under specific directives, such as Machinery, ATEX, Pressure Equipment, LVD, Lifts, Radio Equipment, and others, typically requires CE marking, even if it's for in-house use. Although with CE being self-declared, the extent to which this is actually verified for a one-off in-house equipment is debatable.  It's important to differentiate between internal use as a development prototype and equipment that is operational on an in-house shop floor. Employees and operators using the equipment are effectively third parties and should be able to trust that any equipment they use is appropriately safety certified.

I totally agree with that. The thing is that they ask us to pass an external safety certification and get CE marked, but they have different requirements. We need to check if we can self-certify the product for CE marking, so we don’t need to conduct 2 external certifications (one related to SIL and the other one related to CE marking)

In my previous job, quality assurance was done by a different department (we just received the requirements and redesign requests). Now we need to handle this in the engineering department, so we’ll need to familiarize with this

[Siwastaja]

We need to check if we can self-certify the product for CE marking

That's (emphasis added) a weird way to say it. Assuming the product does not below in one of the few regulated classes, you either
* do not need to certify at all, or
* you MUST self-certify

CE in most cases is self-certification.