A classic question you might think is, what does CE marking of a product really cost? Well, as a consultant, one should be able to answer that, and at the same time, it is like answering how long a string is… Is it the EMC directive (EMCD) only, or is it the low voltage directive (LVD) and EMC or LVD, EMC, and ATEX? Then, of course, there is the status it is today, what has been done and not and what the customer wants to do themselves and what to outsource. So from EUR 0 to EUR 100,000 (oops!). It is not an exact science, but I will try to reason a bit about it.
First, the requirements analysis
Do you know what the requirements are for your product? If not, you need to 1) start reading the Directives and see if you fall within the scope and 2) find which standards are relevant. This is, of course, something you can do yourself, but it is time-consuming and a bit tricky. The end result can also feel a little uncertain. This is a well-defined task for a consultant. You may end up with costs of around EUR 1,000-2,000 depending on the complexity of the product.
Then we think about which directive we are talking about
It is safe to say that it is more expensive to achieve product compliance if there is a need for a third-party review or Notified Body. Fortunately, not many directives require it (most are self-declaring) but for example, some classifications of Explosive Hazardous Areas (ATEX) require this. Then the price tag will increase rapidly.
EMCD can also be included here even though there is no requirement for a Notified Body. It is almost impossible to claim compliance with an EMC standard without doing a test in a test lab. An EMC test costs around EUR 5,000-10,000 in Sweden and EUR 2,000-5,000 in China.
If we instead talk about LVD and the Machinery Directive (MD), it might be a little easier again. MD, you can do most things yourself by, for example, following the methodology in my blog post on the subject. However, I would say that risk assessment can be good to bring in external help. This requires both a working methodology to get good and help with assessments. A simple risk assessment may be around EUR 1000-2000. The cost of the remaining work in the CE marking process depends on how much is to be done by the consultant and what is done in-house. Should the C standard be reviewed? Are the checklists already available? Should instructions be created? Should both initial and final risk assessment be done? How long is a string?
Are functional safety features required for the machine?
Say that you have a machine to be developed from the ground up and that you are developing the control system for it. Well then, it is interesting to know if the control system should be used in risk reduction. If this is the case, you end up in EN 13849-1, which can be enormously extensive depending on the required risk reduction. A simple safety function for PL = b can be easily put together and documented. In contrast, a machine where most safety functions are PL = d functional safety can be an essential part of the development budget for the machine.
What does the user manual cost?
Again, it depends. First and foremost, not all directives require instructions for use, but both LVD and MD do so, so this is a crucial issue. It’s basically about the level of ambition. Examining an instruction manual that a customer has set up against basic requirements in the directive is not that much work, say EUR 800. Composing an instruction manual that meets the most basic requirements of the Machinery Directive is fairly easy. If you make simple hand-drawn sketches (style points are not awarded in the CE world) or photos (say EUR 1500-2500 for a fairly simple product). But instead of creating graphic pictures and drawings, and at the level that I know you can lie, we are talking EUR 5,000-10,000.
So, what does it cost then, really?
How can this reasoning be wrapped up? Well, to begin with, the post is not to be seen as a quote (although it may look like that when I mentioned concrete figures). Still, as you can imagine, it is about looking at the specific product, but the purpose is to give a hum about price levels. It costs money to use consultants, and you can save a lot by doing a lot yourself, but at the same time, you should not forget your own time, lost time in production, etc. It’s a lot about choosing your battles, I would say. Everyone should do what they do best is a key word in our business, and I think it should apply to all businesses.
But why does it have to cost a lot of money?
Yes, it is actually highly relevant. Some costs do not come from testing in external labs, etc., but much of the expenses come from not having control over your requirements when you start the project. Instead of working with CE marking, I have here reasoned quite a lot about how you make sure the various steps CE marking consists of are instead smeared in the development process so that, for example, risk assessment is taken up already at the sketch stage, etc. If you then have templates and methodology ready for how to proceed with a risk assessment, you will also get through this quite easily.
If you want to read more about CE marking as a concept, you can read our article on market access in the EU market here. If you have other questions, please feel free to contact us.