STEP BY STEP GUIDE TO CE MARKING

 

This “Step by step Guide to CE Marking” summarises the procedure to be followed by a

manufacturer to achieve successful CE marking of his products. 

 

 

Step 1: Identification of the applicable legislation

 

1-1-           Check that the product is covered by EU legislation

 

 If there is no EU legislation applicable to the product   Application of the mutual

recognition principle.

 

This principle applies in non-harmonised areas. According to this principle, every

Member State is obliged to accept on its territory products which are legally manufactured and marketed in another Community Member State.

 

Ex: bicycles

  If the product is covered by EU legislation, go to step 1-2

 

 

1-2- Identify which EU legislation applies

 

The EU applicable legislation may be of two kinds:

  “Old Approach” legislation: chemical products…

  “New Approach” legislation: toys, machinery…

Only products covered by New Approach directives require CE marking. If the product is

covered by a New Approach directive, go to step 1-3

 

 

1-3- Identify which New Approach directive applies to the product

Look at the scope of each directive to identify which one is applicable (NB: a product may

be covered by several New Approach directives).

 

 

Step 2: Identify the person responsible for carrying out the formalities

imposed by the relevant New Approach directive

 

The manufacturer, the authorised representative or the importer ?

 

Step 3: Comply with essential health and security requirements

 

Health and security essential requirements are mandatory. They are usually provided in

Annex I of the directives and drawn up in general terms.

 

Step 4: Use the harmonised standards (or other technical specifications)

 

Identify and (if necessary) use technical rules to meet with the essential requirements.

Harmonised standards translate the essential requirements in technical rules. The

manufacturer is free to use the harmonised standards or not. If he does not use harmonised

standards, his product will not benefit from the presumption of conformity.

 

Step 5: Implement the relevant conformity assessment procedure

 

  Classify the product (refer to the text of the directive).

  Identify in the directive the relevant module (conformity assessment procedure) to

assess the product conformity. The applicable module varies according to the category

(and degree of danger) of the product. 8 modules may be used in the framework of New

Approach directives (Modules A to H). They can be used alone or in combination.

• Risk analysis.

• Involvement or not of a “notified body”.

 

Step 6: Provide attestation of compliance with the essential requirements

 

This attestation results from the drafting of the EC Declaration of Conformity and the

technical documentation.

The EC declaration of Conformity must be drawn up and signed by the manufacturer or the

authorised representative even if a notified body is involved in the procedure. The EC

declaration of conformity and the technical documentation must be made available on

request to market surveillance authorities.

Instructions for use must be drafted if required.

 

Step 7: Affix CE marking

 

CE marking symbolises conformity to all the obligations imposed on manufacturers by the

relevant Directive(s). CE marking must be preferably affixed to the product itself. If it is not possible, on the instructions for use or on the packaging.

Marking a product which is not fully in accordance with the requirements of the applicable

directive(s) is an offence in its own right. Affixing the CE mark on a product which is not

covered by a New Approach directive may also constitute an offence.

 

Step 8: Pay attention to amendments/modifications

Attention must be paid to modifications adopted in the relevant sector (legal rules,

harmonised standards and the “state of art”).

 

Consequences of the CE marking

The New Approach is a technical passport allowing industrial goods to circulate freely

within the Community.