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Products need new documentation for sales in Europe

The European Low Voltage Directive, covering most electrical and electronic products for home and office use, changed April 20, 2016. As a consequence, your products need new documentation for sales in Europe!

Existing LVD directive (2006/95/EC) has been replaced by the new directive (2014/35/EU) without a transition period.

WHAT DO I NEED TO DO?

  • All Declarations of Conformity (DoC) need to be updated to refer to the new LVD
  • A risk assessment is required (more information follows)
  • Manufacturers need to put the postal address on the product
  • Importer’s name, registered trademark, and postal address shall be marked on the product for imported goods.
  • Manufacturers, importers, and distributors need to maintain files over traded products that are available for market authorities for a minimum of 10 years.
  • Companies rebranding a product with their own brand becomes the manufacturer and takes over all manufacturers responsibilities, including creation and maintenance of a technical file

 

The new requirements come as a common change, covering 8 different directives, among them LVD.

THE MAIN OBJECTIVES FOR THE CHANGED DIRECTIVES ARE*:

  • Improve the Market Surveillance
  • Improve traceability
  • Clarify obligations for manufactures, importers and distributors
  • Improve the consistency between the different directives

 

* Changes are in alignment with the New Legislative Framework, Decision 768/2008.
The Low Voltage Directive – 2014/35/EU can be found here.

RISK ASSESSMENT

The new LVD has a clear requirement of a risk assessment, in order to define all risks the product may represent. It is also clear that only the use of harmonized standards can give “presumption of conformity”.

In practice the assessment is done through a series of steps:

1.  Define the use and users of the product
2. Identify possible hazards
3. Evaluate if harmonized standard(s) covers all possible risks

  • If the evaluation confirms that harmonized standard covers all risks, the assessment process is concluded.
  • If the evaluation exposes risks not covered by harmonized standard, a more extensive risk assessment needs to be performed.

 

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