European Medical Devices Industry Group
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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 ...
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Non-profit
A nonprofit organization (NPO) or non-profit organisation, also known as a non-business entity, not-for-profit organization, or nonprofit institution, is a legal entity organized and operated for a collective, public or social benefit, in contrast with an entity that operates as a business aiming to generate a profit for its owners. A nonprofit is subject to the non-distribution constraint: any revenues that exceed expenses must be committed to the organization's purpose, not taken by private parties. An array of organizations are nonprofit, including some political organizations, schools, business associations, churches, social clubs, and consumer cooperatives. Nonprofit entities may seek approval from governments to be tax-exempt, and some may also qualify to receive tax-deductible contributions, but an entity may incorporate as a nonprofit entity without securing tax-exempt status. Key aspects of nonprofits are accountability, trustworthiness, honesty, and openness to eve ...
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Trade Association
A trade association, also known as an industry trade group, business association, sector association or industry body, is an organization founded and funded by businesses that operate in a specific Industry (economics), industry. An industry trade association participates in public relations activities such as advertising, education, publishing, lobbying, and political donations, but its focus is collaboration between companies. Associations may offer other services, such as producing conferences, holding networking or charitable events, or offering classes or educational materials. Many associations are non-profit organizations governed by bylaws and directed by officers who are also members. In countries with a social market economy, the role of trade associations is often taken by employers' organizations, which also take a role in social dialogue. Political influence One of the primary purposes of trade groups, particularly in the United States, is to attempt to influence p ...
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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 (F ...
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Europe
Europe is a large peninsula conventionally considered a continent in its own right because of its great physical size and the weight of its history and traditions. Europe is also considered a Continent#Subcontinents, subcontinent of Eurasia and it is located entirely in the Northern Hemisphere and mostly in the Eastern Hemisphere. Comprising the westernmost peninsulas of Eurasia, it shares the continental landmass of Afro-Eurasia with both Africa and Asia. It is bordered by the Arctic Ocean to the north, the Atlantic Ocean to the west, the Mediterranean Sea to the south and Asia to the east. Europe is commonly considered to be Boundaries between the continents of Earth#Asia and Europe, separated from Asia by the drainage divide, watershed of the Ural Mountains, the Ural (river), Ural River, the Caspian Sea, the Greater Caucasus, the Black Sea and the waterways of the Turkish Straits. "Europe" (pp. 68–69); "Asia" (pp. 90–91): "A commonly accepted division between Asia and E ...
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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 act ...
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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 ...
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Medicines And Healthcare Products Regulatory Agency
The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably safe. The MHRA was formed in 2003 with the merger of the Medicines Control Agency (MCA) and the Medical Devices Agency (MDA). In April 2013, it merged with the National Institute for Biological Standards and Control (NIBSC) and was rebranded, with the MHRA identity being used solely for the regulatory centre within the group. The agency employs more than 1,200 people in London, York and South Mimms, Hertfordshire. Structure The MHRA is divided into three main centres: * MHRA Regulatory – the regulator for the pharmaceutical and medical devices industries * Clinical Practice Research Datalink – licences anonymised health care data to pharmaceutical companies, academics and other regulators for research * National Institute for Biolog ...
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COCIR
COCIR is the European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry. It is a non-profit trade association, which was founded in 1959, and represents the medical technology industry in Europe. Since 2006 COCIR headquarters are located in Brussels. In 2007, Heinrich von Wulfen became its chairman and succeeded Frank Anton. COCIR is a member of the European Medical Devices Industry Group (EMIG). See also * DICOM * Electronic health record * Electronic medical record * Health Level 7 * Medical device – Medical technology * NEMA The National Electrical Manufacturers Association (NEMA) is the largest trade association of electrical equipment manufacturers in the United States. Founded in 1926, it advocates for the industry, and publishes standards for electrical product ... References COCIR Contribution to Consultation initiated by DG Sanco regarding Community action on health servicesCOCIR establishes a desk in China External link ...
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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 Association. The EEA links the EU member states and three EFTA states (Iceland, Liechtenstein, and Norway) into an internal market governed by the same basic rules. These rules aim to enable free movement of persons, goods, services, and capital within the European single market, including the freedom to choose residence in any country within this area. The EEA was established on 1 January 1994 upon entry into force of the EEA Agreement. The contracting parties are the EU, its member states, and Iceland, Liechtenstein, and Norway. The EEA Treaty is a commercial treaty and differs from the EU Treaties in certain key respects. According to Article 1 its purpose is to "promote a continuous and balanced strengthening of trade and economic relati ...
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Pan-European Trade And Professional Organizations
Pan-European can refer to: * Pan-European identity * Pan-European corridors ** Pan-European Corridor X ** Pan-European Corridor Xa * Pan European Game Information * Pan-European Institute * Pan-European nationalism * Pan-European Oil Pipeline * Pan-European Pension * Pan-European Picnic * Paneuropean Union, a European unification group * Pan-European University * Paneuropean Working Group of the European Parliament * Honda ST series motorcycles, sold as the ''Pan-European'' in the UK & Europe See also * European integration * European political party * Pro-Europeanism * * * Transeuropean (other) * Transeuropa (other) * European (other) * Pan (other) * Proto-Indo-European language Proto-Indo-European (PIE) is the reconstructed common ancestor of the Indo-European language family. Its proposed features have been derived by linguistic reconstruction from documented Indo-European languages. No direct record of Proto-Indo-E ...
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