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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.
Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and placing on the market of medical devices for human use. It repealed Directive 93/42/EEC on Medical Devices (MDD) and Directive 90/385/EEC on active implantable medical devices (AIMDD).
The manufacturer should register their products through their Italian distributor who is not only familiar with the language and local regulations but also has responsibility if he is the "c) other individual responsible for trading medical devices as under article 13, paragraph 2 of legislative decree no. 46 of 24 February 1997" as mentioned in the official form here:
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.
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 ...
Palantir stock fell more than 5% Thursday, adding to Wednesday's 10% drop following a Washington Post report that said the Trump administration has told the Pentagon to plan for massive budget ...
The affected vehicles are the Kia Niro from 2023-2025, Niro EV from 2023-2025 and the Niro plug-in hybrid from 2023-2025.
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.