If an end user imports a product directly from a country outside the EEA for his own use only, does the product require a CE Mark?

Latest thinking from the enforcement authorities is that the end user takes the product into service, therefore no assessment, Declaration of Conformity, or CE Mark is required. The product has not been supplied within the EEA. However the end user may have to take action if interference is caused and […]

Does an assembly of CE Marked sub-assemblies make for a compliant product?

Not necessarily. There are sound technical reasons why this should be so. The final manufacturer takes responsibility for the EMC performance of the completed product. Does the signatory of the Declaration of Conformity go to jail if the product is shown to be non-compliant? Not all offences under the UK […]

What degradation of performance is acceptable for immunity testing? What degradation of performance is acceptable for immunity testing?

The manufacturer may state this in the user documentation, providing the degradation is acceptable to the user and would not compromise safety. If no statement is made, then in cases of dispute, the performance that a user would reasonably expect will be used.

Can compliance with more than one directive be stated on one Declaration of Conformity?

Yes, providing all the relevant information is given for each directive, including the year of manufacture for certificates declaring conformity to the Low Voltage Directive.

Are there any requirements for instructions for use to be in the language of a Member State?

The requirement for products to be supplied with instructions for use is contained within the directive in Annex III, but guidance from the Commission has placed greater stress on the need for such instructions. Regulation 5(6) applies in the UK. It would seem logical that if there must be instructions […]

What constitutes a sub-assembly?

Guidance from the Commission has clarified the definition, and items which are designed, manufactured and intended to form part of an item of apparatus do not have to comply with the directive (only the finished product must do so). If, however, the item would perform a direct function for an […]

How can large systems be declared compliant?

A large installation supplied by a single manufacturer may be considered a system and comes within the scope of the directive. For emission, EN 55011 allows on site testing for products within its scope, but an attempt to create a more general in situ measurement standard in Europe has failed. […]

Who is an authorized representative?

Someone, or a company, empowered by the manufacturer to act on his behalf. For his own due diligence, he should be satisfied that the information provided is sufficient to enable him to issue the Declaration of Conformity, and that he is able to bind the manufacturer to commitments. It is […]

Who signs the Declaration of Conformity when the manufacturer is outside the EEA?

The manufacturer may sign the Declaration of Conformity whether he is located inside or outside the EEA. A manufacturer outside the EEA may delegate his authorized representative within the EEA to issue the Declaration of Conformity and affix the CE Mark. Supply to an authorized representative does not come within […]

When can a standard be used for self-certification under the standards route?

When it has been harmonized, i.e. it has been published by CENELEC or ETSI and transposed into a national standard in at least one Member State AND it had been listed in the “Official Journal of the European Communities”. Note that to use this route, the harmonized standard(s) applied must […]