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CE Marking Regulations for European Union

In the European market, a product with CE marking can be transported freely. It is a certification for goods sold within the European Economic Area (EEA) conforming that the health and safety standards have been met. This certification can also be applicable on goods marketed outside EEA produced to the EEA standards. Let’s see in detail how and where the CE marking is applicable

Points covered in this article are

1. What is CE Marking?

2. Where is the CE marking applicable?

3. Rules for meeting CE standards

4. CE certification process

5. Product group that require CE certification

6. Non compliance

1. What is CE Marking?

There are certain standard set by the EU that the products should meet. This certification implies that the safety, health and environmental protection standards are met. Some products mandatorily require CE marking as per EU specifications. This is not only applicable on products manufactured in the EU but products manufactured anywhere in the world and marketed in the EU

2. Where is CE Marking applicable?

It is applicable on product manufactured and marketed in European Economic Area (EEA). These are mandatory for certain product groups. Products imported to the EU also should conform to EU standards

3. Features of CE Marking

· It implies that the product complies with the health, safety and environmental standards set by the EEA regulations

· Products manufactured and sold in the EU must have CE marking affixed and must be visible and legible

· If the marking cannot be affixed on the product itself it must be affixed on the packaging of the product

· The CE marking/logo on the product should be of specific proportion and size

4. Rules for CE marking

· The products that mandatorily require to follow EU regulations must affix CE marking

· Different categories of product fall under different EU legislation so the manufacturer must be clear which EU legislation they need to apply for their products.

· It is not any quality assurance so does not provide any kind of information to the customers

· It should not be confused with other individual testing. If any other markings are affixed on the product, it should be made sure that the markings do not overlap

5. CE Certification process

The certification can be two types either self-certification or certification by the authorised representative. It shall be based on the type of product and level of risk. If a product involves least risk level, it can be self-certified by the manufacturer by giving a declaration. Steps of certification are:

i. Identify if the product needs CE certification

All products do not require CE marking. So, it has to be investigated if the product needs certification or not. There are different directives applicable for different product categories such as wireless devices, electrical equipments, medical equipments etc

ii. Identify applicable directives

Depending on the classification or type of product compliance requirements are different. Each directive is different from each other. Applicable ‘Harmonised European Norms’ (Standard) known as HENs

iii. Identify appropriate route of Conformity

There are various routes of conformity. Some products may be certified with self certification while some has to be done by authorised representatives. Different ways of certification are

· An assessment of the product by the manufacturer himself

· An assessment of the product by the manufacturer, with additional requirement for mandatory factory production control audits to be carried out by an authorised third party.

· An assessment by a third party with the requirement for mandatory factory production control audits to be carried out by the authorised third party.

iv. Assessment of product Conformity

After defining under which directive, the product falls and what are the requirements of such directive, testing has to be done on the product conformity

v. Compliance to technical documentation

For the certification of the product documentation of the product has to be done. The documentation must include the product details such as description of the product, design and development of the product etc

vi. Make a declaration and affix CE marking

Once it is made sure that the product satisfies all the EU requirements, declaration can be given after the manufacturer or authorised representative is satisfied. The requirements of declaration are:

· Name and address of manufacturer

· Details of the product

· Standards and directives applicable on the product type

· Date of signing declaration

· Information about the authorised person

· A statement declaring that product complies with all the requirements

Once all the EU declaration has been completed the CE marking can be affixed on the product. After the marking is done the product can be marketed in the EEA market

6. Product group that require CE marking

· Active implantable medical devices

· Energy related products

· Explosives for civil uses

· Machinery

· Radio equipment

· Toys

· Products that emit noise

There are also few other product categories within machinery and energy related products

7. Non-compliance of CE

There are instances when the CE marking were misused. Products do not comply with the requirements even when CE marking is affixed. Also, there are cases when the product does comply all the requirements but the mark is not as per the legal specifications. In such case if the authorised person asks for auditing the product documents it has to be submitted

So, the products not only should meet the requirements of EU requirements but the CE Marking should also be as per the specifications. Not all the products sold in the EU require the certification. The product with CE marking implies that it satisfies the EU guidelines or requirements

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