European Directives are published in the Official Journal (OJ) of the European Union (EU).
Each Directive specifies an implementation date. This is the date that identifies when use of the Directive can begin (usually a voluntary requirement).
A Directive will also specify a date on which it becomes effective. This is the date from which compliance with the Directive becomes a mandatory
requirement.
The time period between the implementation date and the effective date is known as the transition period.
European directives do not apply directly to people or products. They are directives from the EU to member governments. The individual governments have to ensure that national laws are created or amended to cover the requirements of the directives. Thus the directives are translated into national law in all member states of the European Union. An important point to note is that the exact requirements for a directive are to be found in national laws and not in the directives themselves. The result of this is that there can be differences in the interpretation or specific implementation requirements, particularly relating to documentation where something that is acceptable in one country would not be passed in another. However, once compliance has been achieved in one state, it is taken to be approved in all member states.
New Approach Directives and the CE Mark
In 1985 the CE Marking system was established. The requirements for CE marking are specified in the "New Approach" Directives. Directives written prior to this did not take the CE Marking into account (Known as the "global approach").
New Approach Directives provide controls on product design and allow harmonization of product safety requirements across all 28 member states of the EU, plus the 3 countries of the European Economic Area (EEA); Iceland, Liechtenstein and Norway.
CE Marking can only be applied to products that comply with all the applicable Directives, one or more of which must be a "New Approach" Directive.
Application of the CE Mark indicates compliance with all relevant European Directives and allows the product to be sold without reference to national regulations.
A official guide to the implementation of European Directives can be found on the official website of the EU:
http://ec.europa.eu/enterprise/newapproach/legislation/guide/
Meeting the Requirements
Each Directive provides a set of "essential health & safety requirements" (EHSR’s). These essential requirements relate to product safety and call for a minimum level of protection against injury to persons or damage to property. EHSR’s are general in nature and do not identify specific design criteria.
The EU develops harmonized standards known as European Norm (EN) standards. Each EN standard defines criteria for meeting essential requirements. Compliance with the applicable standard therefore infers compliance with the directive (known as presumption of compliance).
This is not the only way to comply with the essential requirements of a Directive, but it is probably the most straightforward. In industries where the state-of the-art is ahead of the published EN standards, other standards (including ISO or a company’s own standards) may be used to demonstrate compliance with the EHSR’s of the directive. It must be stressed that this is not normally an option where a suitable EN standard exists.
The manufacturer of the product may choose to undertake the evaluation and testing to European standards themselves if they have suitable resources and expertise available.
The use of a Notified Body (an EU approved external test laboratory) is not normally mandatory to demonstrate compliance with most directives, although their knowledge, expertise and impartiality in assessing your product may make it advisable to do so.
There are a small number of instances, (such as with certain types of machinery) which must be approved by a Notified Body before being placed on the market. Refer to the text of the specific Directive or contact a Notified Body for details.
Information relating the compliance of the product (test reports, design information etc), commonly know as a "Technical File" should be stored in such a way that it can be retrieved within a reasonable amount of time if required. This information (particularly if commercially sensitive) does not need to be freely available to the public, however it must be available to anyone having reasonable cause for enquiry, such as members of H.M Trading Standards or The Health & Safety Executive (in the UK). This applies to similar, governmental organisations within the other European member states.
Member states are restricted from hindering the free movement of goods that are properly marked – they must have a good reason for doing so, such as the investigation of an accident or a complaint involving the product. CE marked product will be assumed to comply with all applicable directives, unless it can be proved otherwise.
EC declarations of conformity
These documents are drawn up by the manufacturer (or representative within the EU, if the products are imported). An EC declaration must be supplied when requested.
This declaration states:
The name of the manufacturer
The product(s) it refers to
The directive(s) that it complies with
The applicable European Standards
References to test results
The person responsible within the EU who is responsible for placing the product onto the market
The year in which the declaration was first issued
