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European Authorized 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 produced by manufactures outside of the European Union, especially in the medical devices industry, instigated the need for Authorised Representatives. As clarified in the Medical Devices Directive amendment (93/42/EEC), 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. Medical Device Regulation ( MDR) and in vitro diagnostic Medical Device Regulation ( egulation_(EU)_2017/746 increases obligations of E.A.R in the field of surveillance of medical dev ... [...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 a particular result without dictating the means of achieving that result. Directives first have to be enacted into national law by member states before their laws are ruling on individuals residing in their countries. 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. Justification There are justifications for using a directive rather than a ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
(93/42/EEC)
The Medical Device Directive (Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, OJ No L 169/1 of 1993-07-12) 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 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 being repealed and replaced by the 2017 EU Medical Device Regulation (EU 2017/745), effective on 26 May 2021. See also * European Medical Devices Industry Group The European Med ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
CE Mark
On commercial products, the letters CE (as the logo ) mean that the manufacturer or importer affirms the good's conformity with European health, safety, and environmental protection 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), but is also found on products sold elsewhere that have been manufactured to EEA standards. 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. "CE" is the abbreviation of ( French for "European conformity"). Meaning The mark on a product indicates that the manufacturer or importer of that product affirms its compliance with the relevant EU legislation and the product may be sold anywhere in the European Economic Area ... [...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 sale of medical devices for human use. It repeals Directive 93/42/EEC (MDD), which concerns medical devices, and Directive 90/385/EEC, which concerns active implantable medical devices, on 26 May 2021. The regulation was published on 5 April 2017 and came into force on 25 May 2017. Originally approved medical devices will have a transition time of three years (until 26 May 2021) to meet new requirements. 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 post-market surveillance activities. Scope and classificatio ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
CE Mark
On commercial products, the letters CE (as the logo ) mean that the manufacturer or importer affirms the good's conformity with European health, safety, and environmental protection 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), but is also found on products sold elsewhere that have been manufactured to EEA standards. 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. "CE" is the abbreviation of ( French for "European conformity"). Meaning The mark on a product indicates that the manufacturer or importer of that product affirms its compliance with the relevant EU legislation and the product may be sold anywhere in the European Economic Area ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Directive (European Union)
A directive is a legal act of the European Union that requires member states to achieve a particular result without dictating the means of achieving that result. Directives first have to be enacted into national law by member states before their laws are ruling on individuals residing in their countries. 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. Justification There are justifications for using a directive rather than a ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
European Union Legal System
European, or Europeans, or Europeneans, may refer to: In general * ''European'', an adjective referring to something of, from, or related to Europe ** Ethnic groups in Europe ** Demographics of Europe ** European cuisine European cuisine comprises the cuisines of Europe "European Cuisine." [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Regulation (European Union)
A regulation is a legal act of the European Union that becomes immediately enforceable as law in all member states simultaneously. Regulations can be distinguished from directives which, at least in principle, need to be transposed into national law. Regulations can be adopted by means of a variety of legislative procedures depending on their subject matter. Description The description of regulations can be found in Article 288 of the Treaty on the Functioning of the European Union (formerly Article 249 TEC). Article 288 To exercise the Union's competences, the institutions shall adopt regulations, directives, decisions, recommendations and opinions. A regulation shall have general application. It shall be binding in its entirety and directly applicable in all Member States. A directive shall be binding, as to the result to be achieved, upon each Member State to which it is addressed, but shall leave to the national authorities the choice of form and methods. A decision ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
List Of European Union Directives
The following is a thematic list of European Union directives: For a date based list, see the :European Union directives by number Numbering 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". Accounting, auditing, and management control *Seventh Directive: Consolidated accounts of companies with limited liability (Directive 83/349/EEC of 29/6/83). *Eighth Directive: Q ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Medical Devices Directive
The Medical Device Directive (Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, OJ No L 169/1 of 1993-07-12) 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 On commercial products, the letters CE (as the logo ) mean that the manufacturer or importer affirms the good's conformity with European health, safety, and environmental protection standards. It is not a quality indicator or a certificat ... 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 direct ... [...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 (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 Udi may refer to: Places * Udi, Enugu, a local government areas and city in Nigeria * Udi, a place in the Etawah district of Uttar Pradesh, India People * Udi Gal (born 1979), Israeli Olympic sailor * Udi Vaks (born 1979), Israeli Olympic judoka ... marking for devices, common specifications, Eudamed registration, and increased post-market surveillance activities. Classification The regulation introduces the classifica ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
European Union Law
European Union law is a system of rules operating within the member states of the European Union (EU). Since the founding of the European Coal and Steel Community following World War II, the EU has developed the aim to "promote peace, its values and the well-being of its peoples". The EU has political institutions, social and economic policies, which transcend nation states for the purpose of cooperation and human development. According to its Court of Justice the EU represents "a new legal order of international law".''Van Gend en Loos v Nederlandse Administratie der Belastingen'' (1963Case 26/62/ref> The EU's legal foundations are the Treaty on European Union and the Treaty on the Functioning of the European Union, currently unanimously agreed on by the governments of 27 member states. New members may join if they agree to follow the rules of the union, and existing states may leave according to their "own constitutional requirements".TEart 50 On the most sophisticated discu ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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