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CE marking example on a mobile phone charger. The presence of the logo (from French, "conformité européenne" meaning "European conformity") [2] on commercial products indicates that the manufacturer or importer affirms the goods' conformity with European health, safety, and environmental protection standards.
A European Authorised Representative (E.A.R.) serves as a legal entity designated by non European Union (EU) manufacturers, to represent them in the EU and ensure their compliance with the European Directives. The CE certificate and declaration of conformity can only be issued by a company located in the European Union. [1]
The Medical Device Directive—Council Directive 93/42/EEC of 14 June 1993 concerning medical devices—is intended to harmonise the laws relating to medical devices within the European Union. The MD Directive is a 'New Approach' Directive and consequently in order for a manufacturer to legally place a medical device on the European market the ...
Commission Directive 66/683/EEC of 7 November 1966 eliminating all differences between the treatment of national products and that of products which, under Articles 9 and 10 of the Treaty, must be admitted for free movement, as regards laws, regulations or administrative provisions prohibiting the use of the said products and prescribing the use of national products or making such use subject ...
CE Mark. A notified body, in the European Union, is an organisation that has been designated by a member state to assess the conformity of certain products, before being placed on the EU market, with the applicable essential technical requirements. These essential requirements are publicised in European directives or regulations.
European Organisation for Technical Assessment (EOTA) (German: Europäische Organisation für Technische Bewertung, French: Organisation européenne pour l'évaluation technique) is a European non-profit association. Its primary purpose is to draft the European Technical Assessment (ETA) documents. Once ratified, these become EU standards.
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) is a European Union regulation dating from 18 December 2006, [1] amended on 16 December 2008 by Regulation (EC) No 1272/2008. [2] REACH addresses the production and use of chemical substances, and their
The regulations implemented European Union directive 89/654/EEC on minimum safety and health requirements for the workplace and repealed and superseded much of the Factories Act 1961 and Offices, Shops and Railway Premises Act 1963. [2] Since 31 December 1995, all new and existing workplaces have had to comply with these regulations. [3]