For the last 15 years, there has not been a single week in which I have not been asked the following:
“What are the costs of CE certification?”
It is a very understandable question. I am sure that it is on your mind as well. Before you start a new activity, it is good to have an overview of the costs involved. But most people do not realize how difficult it is to answer this question for CE marking.
Actually, the question is similar as going to a builder, say that you want a six-room house on two acres, and ask to know the costs. That question is simply impossible to answer. There are far too many variables. It is the same with CE marking. There are so many variables that can affect the price you pay. You don’t buy CE marking by the pound.
The price of CE certification can differ greatly from one product to another. I have seen prices range from $ 64 to $ 64,000. The price is often affected by which certification procedure applies to the product, whether the company can do some or all of the conformity assessments themselves, as well as the level of support needed to prepare the required compliance documents, Technical File, users manual and product labeling.
Which certification procedure or procedures applies/apply, is based on the technical specifications of a product, as well as its ‘intended purpose’. Only when these factors are clear, the correct CE directives (yes, a product can be covered by more than one CE directive at the same time), European harmonized standards and certification procedure can be determined.
In many cases the CE directives offer two or more certification procedures that may be used. The costs associated with one or the other procedure can vary, and thus this is one of the aspects to keep in mind.
What do you need to know to get an accurate overview of the costs of CE marking?
You need to clarify the following points:
- Which CE directive or CE directives apply/applies to the product?
- Which standards apply to the product? And do these standards have the status of European harmonized standards or not?
- Which certification procedure or procedures apply/applies?
- With this information you can compare quotes from service providers such as test laboratories, certification bodies and consultants and ensure that will provide the same service.
But there is more
To determine the costs of CE certification you also should take into account the following aspects:
a. Are you required to involve a 3rd party certification body, or are you allowed to do self-certification?
The biggest myth about CE marking is:
“To get CE marking, products must be tested and certified by a third party certification body”.
This myth has cost a lot of companies a lot of money. In almost 90% of the cases, the CE marking regulations allow products to be self-certified for CE marking. In other words, you can do the CE marking yourself and you are not required to have the product certified by a third party certification body. Obviously, CE marking self-certification can save your company a lot of time and money.
You too can learn to do CE self-certification. For example, with our ‘Ultimate CE Marking Guide’ it is quite easy.
b. Is it possible for you to do in-house testing/inspections, or do you need to subcontract this?
Many of the required test and conformity assessments can be performed by your company. Simply because it is a visual inspection or because it does not require special equipment and test equipment is available (or can be obtained).
c. Do you want to combine CE marking with other (private) certifications/markings (e.g. GS, TUV, NEMKO, DEMKO, SEMKO etc. etc.)?
There are testing and certification bodies that are accredited for various international markings and certification schemes. With one basic test in combination with some targeted additional test, your product can be approved for many markets, and thus you can spread the costs of certification over a bigger number of products.
d. Can you buy CE approved parts or components that will make your own CE marking effort easier?
I can give you a practical example: one of my clients manufacturers a small optical inspection tool (a small car with a video camera) with a RF remote control module. The RF module was purchased from a vendor, and it already was CE approved. And as a result, my client did not have to test his product against the RF standards.
e. Have you thought about the internal company resources you require for the CE marking? Do these have to be included in your budget?
What I mean here is the costs of the persons who will have to dedicate time to the initial CE marking, and afterward to keeping updated with the regulations and standards.
f. Have you taken into consideration that the existing design may not pass the conformity assessments, and that it needs to be modified? How much time and money does it cost us to make design changes? How much does it cost us to do the re-testing?
As you can see there are many things to consider. All aspects mentioned above have an effect on the costs. In most cases you can do a lot yourself, possibly with some guidance and instructions, and thus saving a lot of money. Risk analysis’, the compilation of the Technical File, conformity assessment against essential requirements of the directives and standards, the Declaration of Conformity. These all can be done by you or your colleagues, if you invest a little time in learning how to do it.
The biggest costs in CE certification are inherent to the time that test laboratories, certification bodies and consultants need to spend on your products. I think that by looking at your product, you can already estimate that the time investment for conformity assessment, risk analysis or the compilation alone is at least a full day of work, and likely more. Multiply this with a reasonable hourly fee, and you will conclude that the cost of CE certification easily exceeds $1500. For product testing alone you often need several days to run the required test procedure. I have seen wear and tear tests for construction products that take 1 month!
Wear and tear test simulating sun-rain
Surely, you may find laboratories and consultants in the market who claim they can do it for a very low fee. My experience and the experience of my clients with these companies is that the provided services are very cheap as well. Please consider this: the CE marking is about providing evidence that the product complies with the applicable requirements. In the case you have to involve a test laboratory or certification body, it is better to use a well-established, reputable company than a cheap unknown company. Because when your product’s CE compliance is challenged, its acceptance by authorities and your customers depends on the reliability of the (test)certificate and report.
My advice: if you want to save money on CE certification, do as much as you can yourself. Don’t depend on third parties and consultants. Perform the conformity assessment. Prepare the Technical File. Carefully prepare your product for compliance testing, if you cannot conduct it yourself. But trust me: you can achieve a lot yourself, if you spend a little time to get familiar with the rules. And if you need some guidance: check out the information products or workshops on our website.
Hello Han, I was wondering if you could possibly point me in the right direction, i am in the process of manufacturing a range of socket/switches etc however the electrical components for these will be bought in from a certified source, if I’m just making the surrounds for them do you think this would legally require any certification on my part to enable me to sell them or would i be ok due to the electrical components being previously tested ?
Regards
Ben Naylor
Hi Ben,
Thank you for your question. First, you have to be aware that because your company is selling these sockets and switches in the market under its name, it is responsible to ensure the compliance with the regulations. If the approved electrical components come from one supplier, and these components have been tested as one configuration against the appropriate standards, you can base your CE marking on theirs. Make sure that you receive the documented proof of CE compliance from the supplier.
If the components come from different suppliers, they have never been tested working together. While individual components may comply with standards for the component, it does not mean automatically that the combined components comply with the standards for sockets or switches. So in that case I would recommend you to have the sockets/switches tested/certified.
BTW. Please note that plugs and sockets are exempted from the Low Voltage Directive and the CE marking… (See the text of the Low Voltage Directive).
Thank you, really useful information. I’m just working on importing fancy dress items to the UK so it’s all very helpful! Do you think this is something I can do myself? Thanks in advance for any help you may be able to offer
Please check carefully if you need CE in the first place. Dresses do not require CE.
Han,
We have a client with a medical diagnostic product, patch & meter to read. Does he need patient clinical trials to proof his methode to be accurate and does he need to demosntrate in more than 1 EU state, how many patients does he need for the trials and how longer process after the data is ready to be filed to recieve the ce mark. further what are the filing fees and approx. costs for the clinical
Thanks
60950 safety testing. We are being quoted $4000 but think this excessive as most of the tesing pertains to mains electricity and electrocution potential. Our product works of 4.5V and average current consumption is 3mA, it has no dangerous components and will only set on fire if you put in one. Is there a way to self certify a product like this without paying for expensive testing, most of which will be marked n/a.
Thanks for any help
John
Hi Han
We have a battery powered handset product (similar to a TV remote controller). We have done all of the EMC and R&TTE testing needed for the product but we are not sure about the 60950 safety testing. We are being quoted $4000 but think this excessive as most of the tesing pertains to mains electricity and electrocution potential. Our product works of 4.5V and average current consumption is 3mA, it has no dangerous components and will only set on fire if you put in one. Is there a way to self certify a product like this without paying for expensive testing, most of which will be marked n/a.
Thanks for any help
John
Thx for the post…
Calibration services takes important place in every industry. We are able to make exact experiments due to it with confidence. To get a reliable calibration services provider, i have a recommendation which is Sime-Sirim Technologies Sdn Bhd whereby it is an ISO certified lab in malaysia.
Hi Han,
Informative site. Do you have a list of the test lab can do the following stds?
ASIA region if possible
ETSI EN 301 489-1 V1.8.1:2008
ETSI EN 301 489-12 V1.2.1:2003
IEC60950-1
FCC Part 15B
I am sourcing a lab that can do these including the certification for competetive cost.
Thanks a lot
I don’t have it at hand. But maybe some will respond to this comment. Are you sure you will not need a Notified Body?
Hi
I would like to Know under which directice do i have to take the CE mark for Dental Implants and how much will it cost for the Same.
reg…
Sean Dsilva
Have a look at the Medical Devices Directive (93/42/EC).
Hi!
I want to import to Europe BBQ gas grill. can you tell me please what will be the cost of CE for this product.
Thanks!!!!
Hi Han, Nice internet site. I’m looking into importing a towbar which from what I understand have passed ISO standards. Towbars need to pass 94/20/EC for CE conformity. Could these ISO testing results be used in the technical file before self-declaration, or would the tests need to be carried out again by a third party (as testing equipment may be costly) in order to gain a certificate of conformity? Any idea on costs on testing? Thanks again for your great site!
The 94/20/EC is a European Directive alright, however it is not a directive that requires a CE marking. Also it’s conformity assessment procedures are quite different from those of the CE Directives. I haven’t read the 94/20/EC, and I am not familiar with its requirements and certification procedures.
Thank you Han. It was fantastic. By any chance can you tell me about the cost of CE for a gel documentation system?
Regards
M.R.Bassami
Which Directive applies? Which standards apply? Do you have other product certifications? Please answer me via email.
Very useful and informative for someone who hasn’t a clue about CE. Thank you
Thank you Emma. Its important for us to get feedback. I am glad you like the post.