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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.
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 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 ...
Under the General Product Safety Regulation (GPSR) — Regulation (EU) 2023/988 — products marketed in the EU must include an Authorized Representative if the manufacturer is located outside the European Union, starting from the 13th of December, 2024. This representative acts as a contact point for competent authorities in EU member states ...
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
EU Regulation 2024/1975 of 19 July 2024 layed down the rules for the application of Directive 2014/90/EU of the European Parliament and of the Council, as regards design, construction and performance requirements and testing standards for marine equipment and repealing Commission Implementing Regulation (EU) 2023/1667 [3]
Regulation; European Union regulation: Title: Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance)
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related to: eu ce marking regulations for healthcare workers california