CE MARKING ACTION PLAN

It is vital that business adopt a purposive approach when implementing new legislation. This is also true for product falling under the New Approach directives.

The following convenient plan of action assist in the correct use of the CE Marking as legally required by these New Approach directives.

This plan of action discusses in chronological order all aspects of importance to the business – from becoming acquainted with the New Approach directive to the ultimate application of the CE marking.

1. GATHERING INFORMATION

It is important that the businessman starts by gaining an insight in the New Approach directive(s).

The collection of articles from newspapers, magazines and trade journals, the exchange of knowledge with other businessmen in the same branch, consultation with advisors, visits to seminars and participation in workshops are just a few of the may possible ways of collecting this information.

It is important that the businessman approaches various authorities for advice with regard to the new legislation concerned with this product.

2. WHO IS RESPONSIBLE?

Before any further measures are taken it is important to first investigate who is ultimately responsible for the conformity of the product and the CE-marking.

For European product this is usually the manufacturer.

When however the products originate from outside the European Economic Area (EEA), an authorize manufacturer’s representative or the importer will be the person who will have to take the following steps, not the manufacturer outside the EEA.

It should be noticed that an European Manufacturer, who places his product on his national market only, must also affix the CE-Marking.

To a product that is solely produced for own use no CE-Marking should be affixed. But the product will still be required to be in compliance with the essential requirements of the relevant directives.

3. DOES THE PRODUCT FALL WITHIN THE SCOPE OF THE DIRECTIVE?

Only those directives that are actually of importance to the product have to be used.

Several directives can have to be applied at the same time to one single product.

Consequently the product has to meet the fundamental requirements of all these directives.

The definitions and exceptions as given in the directives should be carefully studied.

It is advisable to obtain sound advice about this before proceeding further.

4. DOES THE PRODUCT COMPLY WITH THE ESSENTIAL REQUIREMENTS?

Whether a product or a design for a product meets the essential requirement of the relevant directive can be assessed by carrying out a risk analysis.

Several standardized methods are available to carry out such an analysis.

When risk analysis shows that a product does not meet the requirements, the product will have to be adapted.

In order to avoid risks the following sequence be complied with:

• First investigate whether a modification of the design can exclude the risk concerned.

• Only than constructional measures can be considered, such as protective attachments.

• If this id not only partially possible, the use of personal protective equipment can be prescribed to the user.

• Finally, when there is no other solution available, warning for the use of the product should be printed on the product label and included in the user instructions

The Harmonized European standards EN 292-1, EN 292-2, EN 414, EN 1441- 1997 en prEN 1050 give information about carrying out an assessment of the risk.

5. DECIDE WHETHER TO USE STANDARDS

The manufacturer or importer can refer to standards that are used for the product in order to prove compliance with the essential requirements.

These are harmonised European Standards and National Standards.

It is important to use European harmonised standards when these are available, as these

standards take account of the essential requirements made in the New Approach directives.

The references of these standards are officially published by the EU.

When no published harmonised European standards are available, then the non-published European standards or national standards can be used.

Unlike the harmonised European standards, there is however not necessarily an inherent agreement between the national standards and the directive.

It is advisable to indicate the references of the standards that are used in the technical construction file (TCF or PMF) and in the EC declaration of conformity.

6. IS APPROVAL BY A NOTIFIED BODY COMPULSORY?

In the case that the directive makes it compulsory, a Notified Body must review the design, test the quality assurance system of the manufacturer during the production and/or test the final product against the essential requirements. The product may be CE marked only after they have given their approval.

The manufacturer is free to call in a Notified Body from an other country to carry out the tests.

Often the manufacturer or the importer is allowed to carry out the tests themselves when the use of the product concerned is not associated with significant risks.

No Notified Body should then be called in.

7. SET UP USER’S MANUAL

The precautions which must be taken for the use of the product, have to be indicated in the manual in de language of the user.

The directives specify sometimes in detail also which further information has to be given in the manual.

In some cases, the manual has to checked by the notified body.

8. DRAWING UP TO EC DECLARATION OF

CONFORMITY

The EC declaration of Conformity should then be drawn up and formally signed.

This declaration should be supplied with each individual product in the language of the country in which it is sold.

One of the appendices of the New Approach directives always states what information is to be given to this declaration.

Note: Some directives have more than one kind of EC declaration.

For example: The Machinery directive requires that a IIA, IIB or IIC declaration should be supplied with the product, depending on whether the product is a finished product, a machine part, or a safety component.