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Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin (Text with EEA relevance)
Oversee the Notified Bodies that ensure medical device manufacturers comply with regulatory requirements before putting devices on the market. Operate a quality surveillance system to sample and test medicines to address quality defects and to monitor the safety and quality of unlicensed products.
The EUR.1 movement certificate (also known as EUR.1 certificate, or EUR.1) is a form used in international commodity traffic.The EUR.1 is most importantly recognized as a certificate of origin in the external trade in legal sense, especially within the framework of several bi- and multilateral agreements of the Pan-European preference system (the European Union Association Agreement).
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.
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 ...
The country of origin is determined based on the origin requirements provided in the rules of origin applied to the product at hand. In its simplest case, the country of origin will be the country in which the product is wholly obtained or produced. For instance, rice grown and harvested in Vietnam is considered as originating in Vietnam.
Rules of origin are the rules to attribute a country of origin to a product in order to determine its "economic nationality". [1] The need to establish rules of origin stems from the fact that the implementation of trade policy measures, such as tariffs, quotas, trade remedies, in various cases, depends on the country of origin of the product at hand.
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).