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Italian Device Registration
The Italian Ministry of Health (MOH) has implemented mandatory procedures for the Italian registration of medical devices as of 1 May 2007. Overview Placing a Medical Device into the European market is contingent upon compliance with the Medical Device Directive (93/42/EEC). While this directive applies in all member states of the European Union, each member state has its own way of implementing the directive within their country, essentially adding regulations to the directive and creating local legislation. An example of such local implementation of the Directive is now present in Italy. Italy requires, in addition to the CE marking (as opposed to the essence of the CE marking which is “Free Circulation of Goods”), that ALL Medical Devices to be placed in the Italian market will go through a Device registration process. This process is similar to the pre-market notification requirement for Class I Medical Devices (as stated in the European Directive MDD 93/42/EEC Articl ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Ministry Of Health (Italy)
The Ministry of Health ( it, Ministero della Salute) is a governmental agency of Italy. Its headquarters are in Rome ." Ministry of Health. Retrieved on 26 April 2011. and is led by the . The Ministry developed the Italian Food Pyramid (''Piramide Alimentare Italiana'') to guide food and meal planning. The divisions show healthy intake of water, fruits and vegetables, starches (bread, biscotti, pasta, etc.), protein (meat, cold cut meats, eggs, fish, etc.), milk and dairy, and occasional uses (oils, sweets, and alcohol). The pyramid is intended to repr ... [...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] |
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] |
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] |
Law Of Italy
Law is a set of rules that are created and are enforceable by social or governmental institutions to regulate behavior,Robertson, ''Crimes against humanity'', 90. with its precise definition a matter of longstanding debate. It has been variously described as a science and as the art of justice. State-enforced laws can be made by a group legislature or by a single legislator, resulting in statutes; by the executive through decrees and regulations; or established by judges through precedent, usually in common law jurisdictions. Private individuals may create legally binding contracts, including arbitration agreements that adopt alternative ways of resolving disputes to standard court litigation. The creation of laws themselves may be influenced by a constitution, written or tacit, and the rights encoded therein. The law shapes politics, economics, history and society in various ways and serves as a mediator of relations between people. Legal systems vary between jurisdictions, ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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