Harmonised standards and European directives for CE marking

Europe

What are the harmonized standards?

The harmonized standards are the rules that describe how to verify the requirements laid down by the directives on safety, health and environmental protection.

By whom are processed the harmonized standards?

Harmonised standards are drawn up by the European standards organisations: CENELEC for electrical/electronic industry products, ETSI for products in the telecommunications sector, CEN for the products of other sectors.

What is determined in the harmonised standards?

Harmonised standards determine the suitability of a certain method of verification to presume conformity with directive. These standards are called "harmonised", when their references shall be published in the official journal of the European communities (OJEC) in relation to a directive. The complete application of harmonized standards allows the manufacturer to put the product to market without previously subjecting the technical construction file to a notified body. Also allows the manufacturer, If suitably equipped, to carry out internal audits in test labs. Otherwise, can contact a trusted test lab.

EC directives are mandatory?

Yes, the directives are mandatory. The manufacturer (If the product is manufactured in the EEA – European Economic Area) or importer (If the product is imported) is obliged to draw up a technical dossier containing the tests to which the product has been subjected. The tests are specific for each product category and the technical file must be produced on demand to the national supervisory authorities.

EC rules are voluntary?

On the term “volunteer” There is still confusion. EC directives do not make it compulsory to adopt harmonized standards, However it is always necessary to demonstrate the conformity of the product to the requirements of the directives applicable to the product. It is in fact possible to choose other technical and procedural solutions to comply with the essential requirements set out in Directives. These solutions typically require more in-depth technical assessments and the involvement of a notified body. Although more challenging, the latter is the only feasible route in the case of products which due to their technical characteristics can not be evaluated by fully applying the harmonized standards.

When to consult a notified body?

The intervention of a notified body is required when all the applicable harmonized standards are not executed in full. The costs in this case are more especially since the test methods out of the standard must be previously evaluated, developed and implemented.

What is the fastest way to make the product comply with directives?

The fastest route, cheaper and more protective for the manufacturer is the full adoption of all harmonised standards applicable to the product, These are the recipes developed and tested over time in order to check the conformity of the product with the requirements of the directives.

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