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European Authorised Representative
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. Overview Regulation of goods manufactured outside the European Union, particularly in the context of consumer product safety, led to the establishment of requirements for EU Authorized Representatives. 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 13 December 2024. This representative acts as a contact point for competent authorities in EU member states and ensures that the product complies with applicable safety and traceability requirements. GPSR covers only products that do not fall un ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
European Directives
A directive is a legal act of the European Union that requires member states to achieve particular goals without dictating how the member states achieve those goals. A directive's goals have to be made the goals of one or more new or changed national laws by the member states before this legislation applies to individuals residing in the member states. Directives normally leave member states with a certain amount of leeway as to the exact rules to be adopted. Directives can be adopted by means of a variety of legislative procedures depending on their subject matter. The text of a draft directive (if subject to the co-decision process, as contentious matters usually are) is prepared by the Commission after consultation with its own and national experts. The draft is presented to the Parliament and the Council—composed of relevant ministers of member governments, initially for evaluation and comment and then subsequently for approval or rejection. Justifications Directives co ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Regulation (EU) 2023/988
The General Product Safety Regulation (GPSR) is a European regulation on consumer protection. It replaces Directive 2001/95/EC on general product safety. The regulation is intended to ensure that products placed on the market in the European internal market do not endanger the health and safety of consumers through a high level of consumer protection. Scope The regulation applies to products placed on the market or made available in the EU. If certain other harmonized legal provisions apply to these products, they are fully or partially exempt from certain obligations, such as the assessment through an internal risk analysis. Some categories of products, like medicinal products, are exempt. The scope of the regulation includes economic operators such as fulfillment service providers and online marketplace operators. Economic operators The GPSR establishes in §3(13) the following roles for economic operators: * Manufacturer * Authorised representative * Importer * Dist ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Medical Devices Directive
The Medical Device Directive— 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 requirements of the MD Directive have to be met. Manufacturers' products meeting 'harmonised standards' have a presumption of conformity to the Directive. Products conforming with the MD Directive must have a CE mark The presence of the logo on Product (business), commercial products indicates that the Manufacturing, manufacturer or importer affirms the goods' conformity with European Environment, health and safety, health, safety, and environmental prote ... applied. The Directive was most recently reviewed and amended by the 2007/47/EC and a number of changes were made. Compliance with the revised directive became mandatory on 21 March 2010. The Medical Devices Directive is ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
CE Mark
The presence of the logo on Product (business), commercial products indicates that the Manufacturing, manufacturer or importer affirms the goods' conformity with European Environment, health and safety, health, safety, and environmental protection Technical standard, standards. It is not a quality indicator or a certification mark. The CE marking is required for goods sold in the European Economic Area (EEA); goods sold elsewhere may also carry the mark. The mark indicates that the product may be traded freely in any part of the European Economic Area, regardless of its country of origin. It consists of the CE logo and, if applicable, the four digit identification number of the notified body involved in the conformity assessment procedure. Meaning The mark on a product indicates that the manufacturer or importer of that product affirms its compliance with the relevant European Union law, EU legislation and the product may be sold anywhere in the European Economic Area (EEA) ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Regulation (EU) 2017/745
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 regulation was published on 5 April 2017 and came into force on 25 May 2017. Changes Changes compared to the Medical Device Directive include changes in device classification and device scope, stricter oversight of manufacturers by notified bodies, introduction of the "Person Responsible for Regulatory Compliance" (PRRC) and of the economic operator concept, the requirement of Unique Device Identification marking for devices, EUDAMED registration (see below), UDI requirements, and increased postmarketing surveillance activities. Scope and classification Compared to the MDD, the scope of the MDR has been expanded to cover not only the active implantable medical devices previously covere ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Regulation (EU) 2017/746
Regulation (EU) 2017/746 (IVDR) is a regulation of the European Union on the placing on the market and putting into service of in vitro diagnostic medical devices A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assura ... (IVD), repealing Directive 98/79/EC (IVDD), which also concerned IVD. The regulation was published in April 2017 and is closely aligned to the EU regulation on medical devices. Changes compared to the IVDD include changes in device classification, stricter oversight of manufacturers by Notified Bodies, introduction of the "Person Responsible for Regulatory Compliance" (PRRC), the requirement of UDI marking for devices, common specifications, EUDAMED registration, and increased post-market surveillance activities. Classification The regulation introduces, in §47, th ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
CE Mark
The presence of the logo on Product (business), commercial products indicates that the Manufacturing, manufacturer or importer affirms the goods' conformity with European Environment, health and safety, health, safety, and environmental protection Technical standard, standards. It is not a quality indicator or a certification mark. The CE marking is required for goods sold in the European Economic Area (EEA); goods sold elsewhere may also carry the mark. The mark indicates that the product may be traded freely in any part of the European Economic Area, regardless of its country of origin. It consists of the CE logo and, if applicable, the four digit identification number of the notified body involved in the conformity assessment procedure. Meaning The mark on a product indicates that the manufacturer or importer of that product affirms its compliance with the relevant European Union law, EU legislation and the product may be sold anywhere in the European Economic Area (EEA) ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Directive (European Union)
A directive is a legal act of the European Union that requires Member state of the European Union, member states to achieve particular goals without dictating how the member states achieve those goals. A directive's goals have to be made the goals of one or more new or changed national laws by the member states before this legislation applies to individuals residing in the member states. Directives normally leave member states with a certain amount of leeway as to the exact rules to be adopted. Directives can be adopted by means of a variety of European Union legislative procedure, legislative procedures depending on their subject matter. The text of a draft directive (if subject to the co-decision process, as contentious matters usually are) is prepared by the European Commission, Commission after consultation with its own and national experts. The draft is presented to the European Parliament, Parliament and the Council of the European Union, Council—composed of relevant min ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
European Union Law
European Union law is a system of Supranational union, supranational Law, laws operating within the 27 member states of the European Union (EU). It has grown over time since the 1952 founding of the European Coal and Steel Community, to promote peace, social justice, a social market economy with full employment, and environmental protection. The Treaties of the European Union agreed to by member states form its constitutional structure. EU law is interpreted by, and EU case law is created by, the judicial branch, known collectively as the Court of Justice of the European Union. Legal Act of the European Union, Legal Acts of the EU are created by a variety of European Union legislative procedure, EU legislative procedures involving the popularly elected European Parliament, the Council of the European Union (which represents member governments), the European Commission (a cabinet which is elected jointly by the Council and Parliament) and sometimes the European Council (composed o ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Regulation (European Union)
A regulation is a legal act of the European Union which becomes immediately enforceable as law in all Member state of the European Union, member states simultaneously. Regulations can be distinguished from directive (European Union), directives which, at least in principle, need to be Transposition (law), transposed into national law. Regulations can be adopted by means of a variety of European Union legislative procedure, legislative procedures depending on their subject matter. Despite their name, Regulations are primary legislation rather than Delegated legislation, regulatory delegated legislation; as such, they are often described as "Acts" (e.g. the Digital Services Act). Description The description of regulations can be found in Article 288 of the Treaty on the Functioning of the European Union (formerly Article 249 Treaty establishing the European Community, TEC). Article 288 To exercise the Union's competences, the institutions shall adopt regulations, directives, decis ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
List Of European Union Directives
This list of European Union Directives is ordered by theme to follow EU law. For a date based list, see the :European Union directives by number. From 1 January 1992 to 31 December 2014, numbers assigned by the General Secretariat of the Council followed adoption, for instance: Directive 2010/75/EU. Since 2015, acts have been numbered following the pattern (domain) YYYY/N, for instance "Regulation (EU) 2016/1627" with * domain being "EU" for the European Union, "Euratom" for the European Atomic Energy Community, "EU, Euratom" for the European Union and the European Atomic Energy Community, "CFSP" for the Common Foreign and Security Policy * year being the 4 digit year * the sequential number. Some older directives had an ordinal number in their name, for instance: "First Council Directive 73/239/EEC". Free movement and trade Goods *Commission Directive 66/683/EEC of 7 November 1966 eliminating all differences between the treatment of national products and that of products w ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
