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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] |
Council Of The European Union
The Council of the European Union, often referred to in the treaties and other official documents simply as the Council, and informally known as the Council of Ministers, is the third of the seven Institutions of the European Union (EU) as listed in the Treaty on European Union. It is one of two legislative bodies and together with the European Parliament serves to amend and approve or veto the proposals of the European Commission, which holds the right of initiative. The Council of the European Union and the European Council are the only EU institutions that are explicitly intergovernmental, that is, forums whose attendees express and represent the position of their Member State's executive, be they ambassadors, ministers or heads of state/government. The Council meets in 10 different configurations of national ministers (one per state). The precise membership of these configurations varies according to the topic under consideration; for example, when discussing ag ... [...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] |
Medical Device
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 assurance before regulating governments allow marketing of the device in their country. As a general rule, as the associated risk of the device increases the amount of testing required to establish safety and efficacy also increases. Further, as associated risk increases the potential benefit to the patient must also increase. Discovery of what would be considered a medical device by modern standards dates as far back as c. 7000 BC in Baluchistan where Neolithic dentists used flint-tipped drills and bowstrings. Study of archeology and Roman medical literature also indicate that many types of medical devices were in widespread use during the time of ancient Rome. In the United States it wasn't until the Federal Food, Drug, and Cosmetic Act (FD&C ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Harmonisation Of Law
In the European Union, harmonisation of law (or simply harmonisation) is the process of creating common standards across the internal market. Though each EU member state has primary responsibility for the regulation of most matters within their jurisdiction, and consequently each has its own laws, harmonisation aims to: * create consistency of laws, regulations, standards and practices, so that the same rules will apply to businesses that operate in more than one member state, and so that the businesses of one state do not obtain an economic advantage over those in another as a result of different rules. * reduced compliance and regulatory burdens for businesses operating nationally or trans-nationally. An objective of the European Union to achieve uniformity in laws of member states is to facilitate free trade and protect citizens. Harmonisation is a process of ascertaining the admitted limits of international unification but does not necessarily amount to a vision of total unifo ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
European Union
The European Union (EU) is a supranational political and economic union of member states that are located primarily in Europe. The union has a total area of and an estimated total population of about 447million. The EU has often been described as a ''sui generis'' political entity (without precedent or comparison) combining the characteristics of both a federation and a confederation. Containing 5.8per cent of the world population in 2020, the EU generated a nominal gross domestic product (GDP) of around trillion in 2021, constituting approximately 18per cent of global nominal GDP. Additionally, all EU states but Bulgaria have a very high Human Development Index according to the United Nations Development Programme. Its cornerstone, the Customs Union, paved the way to establishing an internal single market based on standardised legal framework and legislation that applies in all member states in those matters, and only those matters, where the states have agreed to ac ... [...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 Economi ... [...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] |
European Medical Devices Industry Group
The European Medical Devices Industry Group (EMIG) is a non-profit trade association, and represents the medical devices industry in Europe as defined by the European Union Medical Devices Directives (93/42/EEC). Karen Howes is the current chair person of EMIG. See also * Medical Devices Directive * Medicines and Healthcare products Regulatory Agency (MHRA) * COCIR * European Economic Area The European Economic Area (EEA) was established via the ''Agreement on the European Economic Area'', an international agreement which enables the extension of the European Union's single market to member states of the European Free Trade As ... (EEA) Sources MEDICAL DEVICES - INTERNATIONAL COOPERATION(GHTF) Pan-European trade and professional organizations Economy of Europe {{economy-stub ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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] |
European Union Directives
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, the cuisines of Europe and other Western countries * ''European'', an adjective referring to something of, from, or related to the European Union ** Citizenship of the European Union ** Demographics of the European Union In publishing * ''The European'' (1953 magazine), a far-right cultural and political magazine published 1953–1959 * ''The European'' (newspaper), a British weekly newspaper published 1990–1998 * ''The European'' (2009 magazine), a German magazine first published in September 2009 *''The European Magazine'', a magazine published in London 1782–1826 *''The New European'', a British weekly pop-up newspaper first published in July 2016 Other uses * * Europeans (band), a British post-punk group, from Bristol See also * * * Europe (disam ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Regulation Of Medical Devices
Regulation is the management of complex systems according to a set of rules and trends. In systems theory, these types of rules exist in various fields of biology and society, but the term has slightly different meanings according to context. For example: * in biology, gene regulation and metabolic regulation allow living organisms to adapt to their environment and maintain homeostasis; * in government, typically regulation means stipulations of the delegated legislation which is drafted by subject-matter experts to enforce primary legislation; * in business, industry self-regulation occurs through self-regulatory organizations and trade associations which allow industries to set and enforce rules with less government involvement; and, * in psychology, self-regulation theory is the study of how individuals regulate their thoughts and behaviors to reach goals. Social Regulation in the social, political, psychological, and economic domains can take many forms: legal restrictio ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
1993 In Law
File:1993 Events Collage.png, From left, clockwise: The Oslo I Accord is signed in an attempt to resolve the Israeli–Palestinian conflict; The Russian White House is shelled during the 1993 Russian constitutional crisis; Czechoslovakia is peacefully dissolved into the Czech Republic and Slovakia; In the United States, the ATF besieges a compound belonging to David Koresh and the Branch Davidians in a search for illegal weapons, which ends in the building being set alight and killing most inside; Eritrea gains independence; A major snow storm passes over the United States and Canada, leading to over 300 fatalities; Drug lord and narcoterrorist Pablo Escobar is killed by Colombian special forces; Ramzi Yousef and other Islamic terrorists detonate a truck bomb in the subterranean garage of the North Tower of the World Trade Center in the United States., 300x300px, thumb rect 0 0 200 200 Oslo I Accord rect 200 0 400 200 1993 Russian constitutional crisis rect 400 0 600 ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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