The Single Market
The objective of the European Single Market is to remove barriers to trade throughout the European Economic Area.
The Directives
The European Parliament has issued Directives intended to put the Single Market into practice. A series of Directives (‘The “New Approach Directives”) provide a `level playing field’ for product safety requirements across the European Community. The CE mark shows that a product complies with the appropriate New Approach Directives.
The Scope of Directories
The “New Approach” Directives cover an expanding range of products. These now include construction products used in building, electrical and electronic goods, gas appliances, machinery, medical devices, personal protective equipment, pressure equipment, lifts, toys, telecommunications and several more product lines.
The Law
Each EC directive has to be introduced in the member countries by the laws and regulations of that country.
Product Assessment for CE Marking
Each Directive contains a list of Essential Requirements that the product must meet and a process to assess how the manufacturer demonstrates that the Essential Requirements are met.
The Technical File is the way a manufacturer puts together the evidence that he has met the appropriate Directive or Directives.
For products with a low risk of harm, it is common for a Directive to accept that a manufacturer can Declare Conformity with the Directive without reference to outside testing or verification agencies. For products with higher risks external testing and verification is often required. The Directives detail how a manufacturer declares conformity.
The Role of Standard
A very large number of Standards have been agreed which assist manufacturers in meeting the Essential Requirements of the Directives. A manufacturer should always check these standards or European Norms (EN), to see whether they are applicable to a particular product. However, standards are only a means to meet the Essential Requirements; the manufacturer must demonstrate how all the Essential Requirements have been met.
The Application of CE Mark
Before a product is CE marked, it must comply with all the directives that apply to it. Once the manufacturer has made a written Declaration of Conformity with these standards the product can have the CE mark affixed to it.
Should the CE Mark be fitted to a product which does not comply with all the applicable directives, the manufacturer of the Authorized Representative in Europe can be prosecuted.
Implications for Manufactures
The purpose of the directives is not to ban any products from the European Single Market, unless the product is poorly made or is unsafe. For most reputable manufacturers, complying with the essential requirements of the directives is not particularly onerous and companies that have always taken a responsible attitude to the performance and design of their products will have few problems complying with the New Approach directives. The difficulties that arise are most often with the way a manufacturer demonstrates compliance.
Manufacturers may well find it cost effective to seek outside help in the early stages of complying with the Directives in order to save time and prevent expensive mistakes. However, it is important to be aware that it is rarely necessary to commit to an expensive program of testing and modifications. Unless the Directives which apply to the product specifically require the involvement of a third party for product approval or quality system assessment, the manufacturer can affix the mark without having to involve a test house.