F.A.Q. - Frequently Asked Questions

The European Union (EU) has implemented a system to protect the health of consumers and workers, as well as sales conditions and the environment.

Sotto il “Nuovo Approccio”, le Direttive CE furono create per assicurare la conformità agli standard di sicurezza e qualità all’interno dell’Unione Europea e di alcuni membri dell’EFTA (European Free Trade Association).

Nel 1994, l’UE/CE e l’EFTA si unirono per creare l’Area Economica Europea (EEA), la più vasta area economica del mondo. I membri partecipanti includono Austria, Belgio, Danimarca, Finlandia, Francia, Germania, Grecia, Islanda, Irlanda,Italia, Lussemburgo, Paesi Bassi, Norvegia, Portogallo, Spagna, Svezia e Regno Unito.

La maggior parte delle legislazioni e delle procedure sono ora esistenti e lo scopo dell’armonizzazione è stato completato. Inoltre, sono stati pubblicati numerosi standard (Norme) per la sicurezza dei prodotti, delle macchine, per la compatibilità elettromagnetica e le telecomunicazioni al fine di supportare i requisiti essenziali delle Direttive. Il processo di standardizzazione si evolve in continuazione, con procedure stabilite per coprire tutti gli aspetti di conformità.

Quando esiste uno Norma Europea (EN), è sempre raccomandabile farci riferimento per assicurare la conformità alle Direttive Europee. In alcuni casi possono essere presi in considerazione anche Norme non-EN ma la scelta va giustificata. L’uso di alternative non-Europee può risultare ingiustificato di fronte alla corte e può far risultare il prodotto non conforme. Solo attraverso gli Norme europee armonizzate, insieme ad un processo di valutazione unificato ed accettato da tutti i paesi partecipanti, è possibile fare a meno di test ridondanti e sottomissione dei prodotti ad ogni singola istituzione degli stati membri.

The compliance of a product requires understanding its purposes and methodologies to achieve it. The purposes are explained in laws, known as Directives. The different Directives define the essential requirements. The ways to achieve the purposes are explained in technical standards, known as Harmonized Standards (EN). Directives and Standards must be considered together with the project assessment criteria related to the product. The most important consideration should be the protection of the end consumer (user, operator, buyer, etc.), for whom the manufacturer and/or distributor must minimize the risks in using the product as much as possible.

Presumption of Conformity

This is an expression associated with products that meet Harmonized European Standards. National governmental authorities are required to recognize that devices produced in accordance with Harmonized Standards, published in the Official Journal of the European Community and transposed into national laws, are presumed to comply with the essential requirements of the applicable Directives. When a product does not meet the appropriate Harmonized EN Standards, the presumption of conformity does not exist.

The Directives tell us why we must comply with them and what could happen if we ignore the law. But it is the Harmonized EN Standards that show us how to comply with them (design and evaluation) by providing us with guidelines.

The Technical File is required by Directives to document the conformity assessment and product design. The Technical File must be compiled by the manufacturer or authorized representative and contains documents related to the design, manufacturer, test reports, and operational information demonstrating compliance as required by the Directives.

Documents composing the technical file:

• Declaration of conformity (and/or certificates)
• Name and address of the manufacturer and identification of the products
• Name and address of the European distributor, if applicable
• List of Harmonized Standards followed and/or solutions adopted to meet the essential requirements
• Description of the product (model, name, etc...)
• User manual
• Test reports
• Design details, component list, circuits and diagrams, including everything necessary to understand the solutions adopted to meet the essential requirements.

Depending on the type of product, there are different types of Directives to apply:

Basic Directives

These apply to all product manufacturers and primarily concern trade. It is important to understand the implications of these Directives, especially for manufacturers. Examples of basic Directives that affect most manufacturers and suppliers include:

• General Product Safety Directive – 2001/95/EC
• Product Liability Directive – 1999/34/EC

Generic Directives

These apply to a specific range or group of products, such as products operating within a certain voltage limit (LVD, Low Voltage) or products that may generate RF emissions (EMC, Electromagnetic Compatibility). These Directives cover a wide range of products such as Information Technology Equipment (ITE), Household Appliances, Lighting Equipment, etc.

Specific Directives

These apply to specific products, such as Telecommunications and Medical Devices, as well as other high-risk products, such as machinery falling under Annex IV of Directive 2006/42/EC, or products used in areas with a high risk of explosion falling under the ATEX Directive 94/9/EC.

Involvement of a Third Party may be mandatory, but not in all cases. If the class or type of product is regulated by the Directive, the Third Party must assess the product and issue the certificate before the CE marking can be affixed. Reference should be made to the relevant Directive to see if involvement of the European Notified Body is mandatory for the product in question.

These types of directives take precedence over all others.