|
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] |
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 less formally 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 discussin ... [...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 in Baluchistan where Neolithic dentists used flint-tipped drills and bowstrings. Study of Archaeology, 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 was not until the Federal Food, Drug, and Cosmetic Act ( ... [...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 union, supranational political union, political and economic union of Member state of the European Union, member states that are Geography of the European Union, located primarily in Europe. The union has a total area of and an estimated population of over 449million as of 2024. The EU is often described as a ''sui generis'' political entity combining characteristics of both a federation and a confederation. Containing 5.5% of the world population in 2023, EU member states generated a nominal gross domestic product (GDP) of around €17.935 trillion in 2024, accounting for approximately one sixth of global economic output. Its cornerstone, the European Union Customs Union, Customs Union, paved the way to establishing European Single Market, an internal single market based on standardised European Union law, legal framework and legislation that applies in all member states in those matters, and only those matters, where the states ... [...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] |
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 * COCIR * European Economic Area (EEA) * Medical Devices Directive * 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 accepta ... (MHRA) 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 Article ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
European Union Directives
European, or Europeans, 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 ** European Union citizenship ** 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 (other) * The Eu ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Health And The European Union
Health has a variety of definitions, which have been used for different purposes over time. In general, it refers to physical and emotional well-being, especially that associated with normal functioning of the human body, absent of disease, pain (including mental pain), or injury. Health can be promoted by encouraging healthful activities, such as regular physical exercise and adequate sleep, and by reducing or avoiding unhealthful activities or situations, such as smoking or excessive Stress (biology), stress. Some factors affecting health are due to Agency (sociology), individual choices, such as whether to engage in a high-risk behavior, while others are due to Social structure, structural causes, such as whether the society is arranged in a way that makes it easier or harder for people to get necessary healthcare services. Still, other factors are beyond both individual and group choices, such as genetic disorders. History The meaning of health has evolved over time. In k ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Regulation Of 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 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 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 was not until the Federal Food, Drug, and Cosmetic Act (FD&C Act) in ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
