The European Economic Area ( Eea )

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Chapter 1 1.1 CE Marking The vast majority of the products that are engaged in commerce inside the European Economic Area (EEA) share a common characteristic, the conformity marking CE. The CE marking (which is the abbreviation of the French phrase (‘Conformité Européenne - European Conformity) indicates that the product baring it was designed, produced and inspected in a way that meets the requirements set by the European Union (EU) legislation . The CE mark has very strict image rules and it is placed on a visible place preferably on the product, and where this is not feasible on its packaging, manuals or other supporting documents. Directive EEC/90/385, ANNEX 9 CE CONFORMITY MARKING ‘— The CE conformity marking shall consist of the…show more content…
The CE marking is proof that the manufacturer produces and merchandises the product in compliance with the EU legislation, and implies that he takes responsibility for the conformity of the product. Therefore it is the manufacturer’s duty to place the sign. The visual of the mark is specifically described in the EU law and must be affixed in a visibly way preferably on the product. Only the products that are required by the community’s harmonisation legislation should bare the mark, which should avert the affixing of other markings that can foment the functions of the CE marking . 1.2 The legal regime of notified bodies 1.2.1 The designation procedure The conformity assessment of the goods baring the CE marking can only be effective in a transnational level between the member states of the EU and EEA. Under the scope of the relevant EU Regulations and Directives each member-state, or any other state that has concluded a Mutual Recognition Agreement (MRAs) and Protocols to the Europe Agreement on Conformity Assessment and Acceptance of Industrial Products (PECAs), can delegate competent Authorities (notifying authorities ) with the duty to designate notified bodies, and further on be notified by the European Commission . For example in the UK the Medicines and Healthcare products Regulation Agency (MHRA) is the designating authority for NBs
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