We often hear: “You don’t have to be responsible for it, but if you were to guess?” or “I know it’s like asking how long a string is but, how much will it cost?”
It’s a completely understandable question. And because CE marking is often a legal requirement to be able to sell your product, and because it is often the last step in a long process, it affects both the price tag and delivery time of the product.
Before we start, we would like to point out that these are approximate prices. Many products are unique and innovative, which can make this type of estimation extremely difficult and uncertain. We therefore reserve the right to freely adjust prices from what is described in the article.
Step 1 Requirement analysis: Which laws apply and which standards?
The biggest contributor to different costs between products is the laws the product must comply with. There are many directives/regulations (we’ll just call them directives in the article) within the EU and many products fall under more than one. Many directives set technical and formal requirements for the product (CE marking requirements), such as the low voltage directive and the machinery directive, while some require producer responsibility such as WEEE and PPWD but we do not focus on the latter in this article.
If you are interested in knowing which directives your product falls under, you can test our Legislation Finder Tool. Finding the directives is also the most important and first step in our three-step method for CE marking, namely requirement analysis.
The directives have technical requirements that must be met and so-called harmonised standards are often used to do so. If you meet harmonised standards, you meet the corresponding requirements in the directive. To meet the standard, sometimes a lot is required and sometimes a little, and not infrequently the involvement of a testing lab is required to evaluate and verify that the standard is being met. In addition, one must check whether the product must be certified by a notified body.
A requirements analysis costs from 8,900 to 35,000 SEK depending on the complexity of the product.
Step 2 Gap analysis: What do I fulfil today and what do I lack?
Now that we know what you have to meet (i.e. which directives and standards), the next big question is what you have today. That is, how many of all the requirements that you have to meet, do you currently meet? Are there test reports for all the standards? Are there drawings and schematics that the directives require?
In order to comply with a directive or standard, proof is required, which is usually called the technical documentation or technical file. For all the requirements that you must meet, you must show in some way that you meet them.
What we describe here is what we call a gap analysis, the second step in our three-step process. Where the requirements analysis can be done on a product group or product category, the gap analysis must be done on each unique product. After the gap analysis, you should know exactly what you have to do to fulfil all the requirements placed on your product.
A gap analysis costs between 690 and 2,500 euros.
Step 3 Close the gap: Time to meet the requirements
When we know what the requirements are (Step 1: requirements analysis) and we know our current situation (Step 2: gap analysis) now it’s time to get to work (Step 3: closing the gap) and maybe test the product or produce a user manual that is missing or do that strength calculation or whatever it is that we have discovered is missing.
What can it cost?
Let’s take a few examples to get a feel for what different steps can cost and the time it can take, and also some examples of what a CE mark can conceivably cost. We do not have a definitive price list because there is so much difference between different product types, but in this article we will describe some of the things that affect the cost.
|Requirements analysis||750 – 3 000 EUR||1-2 weeks|
|Gap analysis||600 – 2 100 EUR||1-2 weeks|
|Risk assessment of machine||1 300 – 3 800 EUR||2-4 weeks|
|Risk assessment of consumer product||450 – 1 300 EUR||2-4 weeks|
|Instruction manual machine||3 000 – 5 000 EUR||8-12 weeks|
|Instructions for use simple product||1 000 – 2 500 EUR||3-6 weeks|
|User manual electronic product||2 100 – 4 200 EUR||4-8 weeks|
As you can see, it is very difficult to say what CE marking costs and how long it takes in general terms, but if you use the above guidelines you will at least get a basic understanding.
|CE marking of a machine||2 100 – 21 100 EUR||8-25 weeks|
|CE marking of a lamp||350 – 12 500 EUR||4-25 weeks|
|CE marking of an industrial plant with assembled machines||5000 – 24 000 EUR||12-26 weeks|
|CE marking of personal protective equipment (category I)||1 300 – 8 500 EUR||12-26 weeks|
|CE marking of personal protective equipment (category II and III)||3 400 – 21 100 EUR||12-26 weeks|
|CE marking of medical equipment (class I) and quality systems||6 800 – 17 000 EUR||12-26 weeks|
|CE marking of medical equipment (class II) and quality systems||15 200 – 16 900 EUR||26-104 weeks|
In the blog posts below, we further explore specific product categories. Click on the blog articles to read more.