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Depending on the level of risk of the product, the CE marking is affixed to a product by the manufacturer or authorized representative who needs to ensure that the product meets all the CE marking requirements. In some cases, if a product has minimal risk, it can be self-certified by a manufacturer making a declaration of conformity and ...
As clarified in the Medical Devices Directive — Directive 93/42/EEC [4] — it is required that alongside the CE mark all products must also have an Authorised Representative. As stated in this amendment, an Authorised Representative should serve as a contact point with the EU member states competent authorities.
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.
The Low Voltage Directive (LVD) 2006/95/EC is one of the oldest Single Market Directives adopted by the European Union before the "New" or "Global" Approach. [1] The Directive provides common broad objectives for safety regulations, so that electrical equipment approved by any EU member country will be acceptable for use in all other EU countries.
The UKCA marking (an abbreviation of UK Conformity Assessed) is a conformity mark that indicates conformity with the applicable requirements for products sold within Great Britain. [1] The government intended that it should replace the CE marking for products sold in Great Britain.
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 requirements of the MD Directive have to be met. Manufacturers' products meeting 'harmonised standards' [1] have a presumption of conformity to the Directive.
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Regulation No. 305/2011 [1] (Construction Products Regulation, or CPR) of the European Parliament and of the Council of the European Union is a regulation of 9 March 2011 which lays down harmonised conditions for the marketing of construction products and replaces Construction Products Directive (89/106/EEC).
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related to: ce marking requirements guidance