Are you familiar with the CE certification?
Are you planning to export products to the EU (European Union)?
For manufacturers who want to export to the EU, it is mandatory that the product to be exported has the CE marking on it.
Not only this, it should also fulfill the requirements and criteria of the European directives and regulations.
Once a product is CE certified, it can easily move between the entire EEA (European Economic Area). Even though it seems easy that you have to meet the EU regulations, the process can be complex if proper guidance is not provided.
This blog contains all the information you need to get CE certification for your product. You will understand why you need CE certification and how you can get that for your products.
Table of Content
Chapter 1: What is CE Certification? What Products Require It?
Chapter 2: How to Get your Product CE Certified? 7-Step Process for CE Certification
Chapter 3: Frequently Asked Questions About CE Certification
Table of Contents
Chapter 1: What is CE Certification? What Products Require It?
CE is the short form of Conformitè Europëenne. Since 1985, most of the EU countries have some standards that products need to meet which are being sold there. These are known as CE standards.
For those manufacturers who plan on selling their products in the European Union, they need to have products that meet these standards.
1. What does the CE Certification mark indicate?
Whenever you see the CE certification mark, it means that the particular product meets the requirements set forth by the European Union.
The mark indicates that the manufacturer declares that all the EU’s New Approach Directives have been met.
The biggest misconception people have with the CE certification is that it is required only by the manufacturers in the EU. No, this is not the case.
In fact, as mentioned earlier, the CE certification is for anyone who wants to send their products to the EU. This is the reason why exporters and manufacturers all over the world know about it.
2. Understanding the basics of CE marking
The most important thing to understand here is that when we talk about the CE marking or CE certificate, it is not like the other certificates.
Once a manufacturer gets the product CE certified, it shows as a stamp on the back of the product like shown in the picture.
The CE marking on a product indicated three major things:
- It shows that these products meet the health, environmental and safety requirements of the EU.
- The product is in compliance with the legislation of the EU.
- The product can easily and freely move within the market of the EU.
- What are the CE Directives?
Getting a CE certificate is not as simple as it seems. The manufacturer needs to meet more than 20 directives before getting the green light.
The directives are made at the EU level. Until all these requirements are met, the product is not allowed to circulate in the markets of the European Union.
It is the duty of the manufacturer and the importer to make sure that they comply with all the directives. They also need to do the proper record keeping must be done and it should be made sure that the CE mark should be affixed.
The key is the check the directive that applies to the specific product. A CE mark does not tell you that all the directives have been met.
There are different directives for different “types of products”. For example, there are directives like 2014/35/EU which represents “Low Voltage”.
The name of the directives gives an idea of what type of products they apply to. For example, the Low Voltage Directive is applicable to the electrical instruments and the toy directive is mostly applied to the toys category.
3. Is CE certification a self-declaration?
The CE marking is not like an ISO standard or quality assurance. It does not tell you that the product has undergone any 3rd party testing or it meets any certification by the European test bodies. Depending on the type of product, the requirements vary.
For example, if you buy pressure valves and other products that can pose a threat to safety, health and environment.
You can require the manufacture to take a certificate from some established and recognized authoritative body. Others require declaration of conformity only when inquired about.
In this case, it is a self-declaration by the manufacturers to show that their products meet the EU requirements.
4. When is it mandatory to have CE marking on your product?
It is mandatory when you need to sell your products in the countries of the European Union. The easiest way to understand it is to consider it as a “passport” for products to come and be sold in the EU. It is important where it is required to affix the CE marking.
There are some products that need to meet only one EU requirement while there are some that are subject to many. You need to check all to be on the safe side. It is a legal crime to affix the marking on products that do not meet the EU requirements.
5. Which countries require CE marking on products?
If you have the CE marking on your products, you can easily sell to more than 30 countries and a total of 500 million consumers residing there.
Nearly all the EU members require a CE marking on the importing products, such as France, Spain and Germany, and smaller countries like Czech Republic, Slovakia, and Lithuania.
These directive and regulations are legislative acts adopted by the EU as a whole, which means that they apply across all EU member states and are mandatory.
Outside of Europe, Austria is the country that also asks the CE mark before the products can be sold.
6. Understand which products needs the CE marking and which does not
The general belief is that all the products that are to be sold in the EU require a CE marking or the CE Certificate. However, only if you are the seller or manufacturer of products that fall in the below mentioned categories, you are required a CE certificate.
- Equipment related and used in telecommunication
- Electronic equipment & IT equipment & Machinery
- Appliances used in the household, freezers and refrigerators
- Products that are electromagnetic compatible
- Protective equipment and systems that are going to be used in atmospheres that are explosive
- Protective and personal equipment
- Equipment used for terminal of telecommunications and radio
- Instruments used for measuring.
- Anything that uses batteries or uses any sort of voltage like 110V or 220V a battery to put inside toys, car battery etc) this includes any device like a FitBit or even a telecom.
On the other hand, products like chemicals, some type of clothes, pharmaceuticals, perfumes and food items do not need to have the CE certification on them.
Chapter 2: How to Get your Product CE Certified? 7-Step Process for CE Certification
Getting and ensuring your CE marking is justified and the product meets the requirements of the EU, it is important to follow these 7 simple steps.
1. Know which directive is applicable to your product for CE Certification
Before you go ahead and make sure your product conforms to the standards and directives set by the European Union, it is important to know which apply to your product. There are many and some apply to one product and others to many.
So the first thing to do is to do your homework well. See under which directives your product falls and which one is applicable to your product. Here is some most useful CE Marking Directives:
| NO. | Directive | Subject of Directive |
|---|---|---|
| 1 | 2014/35/EU | Low Voltage Directive (LVD) |
| 2 | 2014/30/EU | Electromagnetic compatibility (EMC) |
| 3 | 2006/42/EC | Machinery Directive (MD) |
| 4 | 2014/53/EU | Radio Equipment Directive (RED) |
| 5 | 2009/125/EC | Energy-related Product (ErP) |
| 6 | 2011/65/EU | The Restriction of the use of certain hazardous substances in electrical and electronic equipment |
| 7 | 2014/68/EU | Pressure Equipment Directive (PED) |
| 8 | 2014/33/EU | Lifts |
| 9 | Regulation (EU) No 305/2011 | Construction Products Regulation (CPR) |
| 10 | 93/42/EEC | Medical Devices (MDD) |
| 11 | 97/23/EC | Pressure Equipment |
| 12 | 2009/105/EC | Simple Pressure Vessels Directive (SPVD) |
| 13 | 99/5/EC | Radio and Telecommunication Equipment |
| 14 | Regulation (EU) 2016/425 | Personal Protective Equipment |
| 15 | 2010/35/EU | Transportable pressure equipment Directive (TPED) |
2. How to follow the CE Marking Directives?
Now, you have some basic knowledge about each directive. And here is the standards that you need to check, because these can help you understand that how to make the product’s design meets the major requirements.
- Harmonized standards
These are the particular European Standards and directives that have references published in the Journal of the European Committees officially.
If a product conforms to these harmonized standards, it means that you can presume that it conforms to all the requirements set forth in that standard.
Applying for these standards can be expensive. It can cost you anywhere from 300 Euros to 1500 Euros. Think of it as an investment.
Even though it is not necessary for the manufacturer to buy the documents, the EU does evaluate the products based on the CE certification.
To check whether your products have matched the harmonized standards or not, go to the official websites of the European Commission.
- Other standards
These are the standards that are general and can apply to many products. This includes directives like the Low Voltage Directive or EMC standard (electromagnetic compatibility standard.
3 . Check what essential requirements are associated with your product
The next step is closely related to step 1. Once you establish which directives are applicable to your product, the next step is to check what they require from you.
This becomes very easy once you know which harmonized standards are related to your product. Check whether your product meets them or not.
Also, see if your product needs to be approved by a conformity assessment body or not. If the product needs to be approved by the body, the number of the conforming body will also be present with the CE marking on the product.
4. Have a proper monitoring system to check
Investing in a CE marking is no joke. You need to make sure there is a proper monitoring system in place.
This system should be dedicated to only bringing your product up to the specifications that are required in the directive which is applicable to you.
5. Check the need for third-party assessments
There are some directives that need a third party to certify and test the product. They are known as Notified Bodies (NB) and are recognized worldwide for the role they play. If you have third-party verification, them you will not go through that hassle.
These bodies are selected by the EU, they are especially given the task of checking the conformity of these products against the directive specifications.
Another task of the NB is to conduct audits, for checking whether the first 3 steps have been completed or not.
There are some particular directives that require NB verification, which are the directives pertaining to the pressure equipment, Equipment and Protective Systems in Potentially Explosive Atmospheres and the Medical Devices, etc.
The other option is to use harmonized standards if this step is not required.
With time, the product categories that require a NB assessment have been reduced by the EU. It is the duty of the manufacturer to take the responsibility of ensuring that the products meet the standards.
6. Ensure there is product conformity
Here is a very important question, how will you evaluate that your product has met the standards set by the directives?
This has been made simple for you. Each directive comes with various assessment procedures that are also called modules. It is up to the manufacturer to undertake these conformity modules. These are 8 in number.
| Module | Explanation |
|---|---|
| A | Internal production control |
| B | EC type-examination |
| C | Conformity |
| D | Assurance of production quality |
| E | Quality assurance of product |
| F | Product Verification |
| G | Unit Verification |
| H | ISO 9001 |
7. Save documents for decades
CE Certification is all about documentation. All the directives let it obligatory to make, save and provide technical documentation when asked for.
This is the proof that shows that a particular product conforms to the special requirements of the directive. All the information should be kept safe for a time period of at least 10 years.
Keep the technical information at hand. Usually, the authorities require it at a very short notice. It is also important to keep it up to date and relevant.
8. Affixing of the CE certification mark
Lastly, producing a declaration of conformity is required. It is a simple one-page document that states who you are, what declarative you have used, and what methods have you used to achieve product conformity to those declaratives.
Affixing the CE mark is an important part. According to principle, the mark should only be affixed once the entire CE certification process has been completed.
This ensures that the product meets all the requirements of the applicable directives. Generally, the affixing is done when the production phase ends.
As per rule, the CE marking should be affixed to the data plate of the product. There are some cases when the mark cannot be affixed in the right place.
Another case is when the dimensions of the product do not support the mark or the mark would not be visible. In this case, the documents that related to the product should carry the mark.
Mostly, you can find the initials CE written on the CE marking. Sometimes, there is a number after it.
This is the identification number of the Notified Body who has assessed the conformity standards and was involved in the production phase of the product.
Chapter 3: FAQs About CE Certification
1. What is the difference between self-declaration and CE certification mark?
If not certified by the Notified Body, the CE certificate is just a self-declaration by the manufacturer. The CE mark shows that the product made by the manufacturer has conformed to the environment, safety and health standards and declaratives set out by the European Union.
2. Does a CE stamp ensure that the product has been made in the EU?
No. A CE stamp or CE marking does not show that the product was made in the EU. What it shows is that the product meets the directives and standards that are required to sell the product in the countries of the EU.
3. Which is the easiest way to get a product CE certified?
The easiest way to get a CE certificate or CE marking for your product is to go for a company that provides these services.
There are so many steps involve that a single manufacturer who does not have experience in the field can find it difficult to get.
4. Whose duty is it to ensure the product is CE certified?
Generally, it is the duty of the manufacturer to ensure that the products they are making are CE-certified.
An important point to remember here, if the manufacturer made the products with the intention of sending them to the EU countries, it is his/her responsibility. If not, he/she is not responsible for it.
Mostly, the importer or product distributor needs to see and check the products, whether those products they are importing or sending in the EU are CE-certified or not.
Conclusion
It can be seen how important the CE certification process is if you are thinking of sending or importing goods in the countries of the European Union.
To do so, be vigilant and know exactly what directives apply to your product. The process is not very complicated and requires only 7 simple steps that we mentioned above.
After you reading all the content of this blog, you must have ideas about whether you need to apply for a CE Marking or not.
Make sure you are properly certified and do not lack behind in conforming to any directive, then CE certification process will not be difficult to understand for you.
