What is CE Certificate?
A CE certificate is a legal requirement of European Union. It is applicable on products which are falling under atleast one harmonised new approach directives. All products do not require to be ce certified. Only those products for which their exists a new approach directive require ce certification.
Many product require CE marking before they can be sold in the European Union. CE marking indicates that a product has been assessed by the manufacturer and is meeting EU safety, health and environmental protection requirements. It is required for products which may be manufactured anywhere in the world, but are then marketed in the European Union.
What is the cost of CE certificate?
The cost of CE certificate can vary from product to product. It also depends on whether a Notified Body is involved or not. We can try to identify the cost heads for getting a CE certificate. The main cost heads are
- Testing Cost: This is the most common “STEP” and is applicable to 99 % of the products. This is also a time taking process
- Technical File compilation- This is related to compilation of technical file- The requirements of the content of technical file vary from one directive to another. It will always require the following three things
- Product Description and Drawings
- Instruction for use
- Risk Analysis
- Certification Cost – this cost will depend upon the directive and its requirement. Every directive gives options of certification available to a manufacturer.
- Surveillance Cost – This is applicable in certain directives and in many such cases it is not optional but mandatory.
For which product CE marking is mandatory?
CE marking is only obligatory for products for which EU specifications exist and require the affixing of CE marking.
How to obtain CE marking?
As the product’s manufacturer, you bear sole responsibility for declaring conformity with all requirements. You don’t need a license to affix the CE marking to your product, however, before doing so, you must:
- ensure conformity with all relevant EU-wide requirements
- determine whether you can assess your product by yourself or if you have to involve a notified body
- put together a technical dossier documenting conformity: find out about technical documentation
- draft and sign an EU declaration of conformity
Once your product bears the CE marking — if the competent national authority requests — you must provide them with all the information and supporting documentation concerning CE marking.
Does My Product Needs a Notified Body to certify ?
Many directives ask for a Notified Body to be involved in CE certification process. Some directives allow for manufacturers to apply CE certificate without involving a Notified Body. If you are not sure- Please send us a email firstname.lastname@example.org with your product details and we will be happy to help you.
What is the difference between Self certification and Notified Body CE certificate?
Many people are cheated by fake Certification Bodies in the name of Self Certification. These certification bodies are one man backed website and have no authority or knowledge about certification. As there is no law to retrain these certification bodies, they continue to flourish in many countries especially Asian countries.
One should know that only a few directives allow for Self certification of products and even these have placed many requirements on the manufacturer. This includes identification of standard, getting a test report ,compiling a technical file before placing CE marking on the product.
What we are seeing is that many manufacturers are bypassing all the steps required by the directive because they are misled into fake certifications rather than self-certification or Notified Body issued CE certificate.
How to verify a CE certificate?
Below are simple checks that one can perform when presented a CE certificate.
- Verify, whether this certificate can be verified online or not.
- Check if the certificate is referring to a technical file and its version
- Verify if the certificate is referring to test report or not
- Check if the certificate is referring to all applicable directive
- Verify if the standard mentioned in the certificate is the latest version or not
- Check if the contact details such as phone and address of the certification body is mentioned on the certificate.
Which Directives require CE Certificate?
- Machinery Directive 2006/42/EC
- Directive on Noise Equipment for use outdoors 2000/14/EC
- Cableway Installations Directive 2000/9/EC
- Directive 2009/125/EC on Energy-Related Products
- Gas AppliancesDirective 2009/142/EC
- Toy Safety Directive 2009/48/EC
- Directive 2011/65/EU on the restrictions of the use of certain hazardous substances in electrical equipment
- Directive 2013/29/EU on Pyrotechnic Articles
- Hot Water Boilers Directive 92/42/EEC
- Directive 2014/28/EU on Explosives for civil uses
- Pressure Vessel Directive 2014/29/EU
- EMC Directive 2014/30/EU relating to Electromagnetic Compatibility
- Directive 2014/31/EU on Weighing Instruments
- Measuring Instruments Directive 2014/32/EU
- Lifts Directive 2014/33/EU
- ATEX Directive 2014/34/EU relating to equipment and protective systems for use in potentially explosive atmospheres.
- Low Voltage Directive 2014/35/EU relating to the making available on the market of electrical equipment designed for use within certain voltage limits
- RTTE Directive 2014/53/EU relating to Radio Equipment
- AIMD Directive 90/385/EEC on Active Implantable Medical Devices
- Directive 2013/53/EU on Recreational Craft
- PED Directive 2014/68/EU on Pressure Equipment
- IVDD Directive 98/79/EC on in vitro diagnostic medical devices
- CPR Regulation (EU) No 305/2011 on Construction Products
- MDR Regulation (EU) 2017/745 on Medical Devices
- Regulation (EU) 2016/425 on Personal Protective Equipment
How to get a CE certificate for your machinery for 2006/42/EC?
STEP 1- Identify all the applicable Directives. At least, Machinery Directive will apply, but others such as RoHS, Battery Directive, EMC Directive may also apply.
STEP2- Identify Relevant standard – EN 60204 (latest harmonised version) will be applicable but more specific standard can also be applicable
STEP 3- After a product has been designed, or during the design stage,we do a risk analysis. We can use EN 12100 for risk analysis. You should imagine different WHAT-IF situation which can pose a risk to the user. For each situation, we can take many action to reduce risk.
Engineering controls and guards are commonly applied controls to reduce risk. For e.g., for a risk posed by phase inversion, manufacturer can use a phase protection relay. All these Risk analysis is a input for machinery improvement and instruction for use – so the more detailed it is the better.
STEP 4: The machine is verified against the latest revision of EN 60204. There are more than 25 inspection points according to EN 60204. One of the checkpoint is effective Ground Bound continuity. Although it may look simple requirement, but it has some specific requirements as mentioned below:
- colour code of grounding wire.
- cross section size of grounding wire.
- A label, which is not easy to remove.
- A effective ground continuity
First, we do the Risk Analysis and get then we test our product against EN 60204 and/or any other more specific standard applicable to the machine and then Apply CE marking
How to make a ce technical file? What are the contents of a CE technical file ?
The contents of CE technical file are defined in the directive clearly. For a Machinery, the technical file should have
- Description of the product
- Drawing of the product
- Intended use of product
- Instruction for use or Instruction manual including installation and maintenance
- Test report as per relevant EN standard
- Risk analysis as per EN 12100 or EN 14971 or other relevant standard
- Declaration of Conformity
- List of Harmonised standards applied on the product
- If your product has components, the CE certificate for all the components.
What is the full form of ce certificate?
The Full form of CE certificate is Conformite Europeanne
What is the correct CE Logo?
In the correct CE logo, the “C” and “E” are formed from two consecutive circles. There is a space between C and E. In case of fake CE logo this space is very less.
In which language shall I make my instruction manual for CE certification?
“Instruction for Use” is known as “IFU”. In some countries, it is known as “Instruction Manual”.
For CE certification, we recommend that IFU is made in the language of the European Union State where the product will be marketed.
Once a product enters any EU country. It is free to move to any other country in EU. It is a good idea to make the IFU in all common European languages. Some of the common languages are
- and also in the target country where you want to export.
What happens if I export my product to Europe without getting it tested?
- There is a risk for rejection of your product by customs.
- A possibility exists, that the machine is rejected by the buyer after arrival. This leads to a dispute.
- It is possible that your buyer will get a notice from local safety officer. Sometimes Local inspectors simply remove the machine even after installation.
- It is also possible that EU monitoring agency test your product. If they find that it is non compliant. They can report it as dangerous or unfit in a European RAPEX Database . RAPEX is a rapid alert system for dangerous non-food products. It is a gateway for exchange of information between EU countries. A company is listed in this, then all future business is difficult.
I have a requirement for CE certificate for a Pressure Equipment (2014/68/EU)?
Equipment Categorised as PED is having some special requirements for design calculation and testing. A equipment is a PED, if the design pressure is more than 1.5 bar Some raw material require PED 4.3 certification. More about PED certificate .