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EU Medical Device Regulation
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 It repealed Directive 93/42/EEC on Medical Devices (MDD) and Directive 90/385/EEC on active implantable medical devices (AIMDD).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 covered b ... [...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] |
Clinical Trial
Clinical trials are prospective biomedical or behavioral research studies on human subject research, human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, pharmaceutical drug, drugs, medical nutrition therapy, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. Clinical trials generate data on dosage, safety and efficacy. They are conducted only after they have received institutional review board, health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial—their approval does not mean the therapy is 'safe' or effective, only that the trial may be conducted. Depending on product type and development stage, investigators initially enroll volunteers or patients into small Pilot experiment, pi ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
European Union Regulations
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 Eur ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Medical Device Design
Due to the many regulations in the industry, the design of medical devices presents significant challenges from both engineering and legal perspectives. Medical device design in the United States The United States medical device industry is one of the largest markets globally, exceeding $110 billion annually. In 2012 it represented 38% of the global market and more than 6500 medical device companies exist nationwide. These companies are primarily small-scale operations with fewer than 50 employees. The most medical device companies are in the states of California, Florida, New York, Pennsylvania, Michigan, Massachusetts, Illinois, Minnesota, and Georgia. Washington, Wisconsin, and Texas also have high employment levels in the medical device industry. The industry is divided into branches: Electro-Medical Equipment, Irradiation Apparatuses, Surgical and Medical Instruments, Surgical Appliances and Supplies, and Dental Equipment and Supplies. FDA regulation and oversight Medica ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
European Parliament
The European Parliament (EP) is one of the two legislative bodies of the European Union and one of its seven institutions. Together with the Council of the European Union (known as the Council and informally as the Council of Ministers), it adopts European legislation, following a proposal by the European Commission. The Parliament is composed of 720 members (MEPs), after the June 2024 European elections, from a previous 705 MEPs. It represents the second-largest democratic electorate in the world (after the Parliament of India), with an electorate of around 375 million eligible voters in 2024. Since 1979, the Parliament has been directly elected every five years by the citizens of the European Union through universal suffrage. Voter turnout in parliamentary elections decreased each time after 1979 until 2019, when voter turnout increased by eight percentage points, and rose above 50% for the first time since 1994. The voting age is 18 in all EU member states e ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
COVID-19
Coronavirus disease 2019 (COVID-19) is a contagious disease caused by the coronavirus SARS-CoV-2. In January 2020, the disease spread worldwide, resulting in the COVID-19 pandemic. The symptoms of COVID‑19 can vary but often include fever, fatigue, cough, breathing difficulties, anosmia, loss of smell, and ageusia, loss of taste. Symptoms may begin one to fourteen days incubation period, after exposure to the virus. At least a third of people who are infected asymptomatic, do not develop noticeable symptoms. Of those who develop symptoms noticeable enough to be classified as patients, most (81%) develop mild to moderate symptoms (up to mild pneumonia), while 14% develop severe symptoms (dyspnea, hypoxia (medical), hypoxia, or more than 50% lung involvement on imaging), and 5% develop critical symptoms (respiratory failure, shock (circulatory), shock, or organ dysfunction, multiorgan dysfunction). Older people have a higher risk of developing severe symptoms. Some complicati ... [...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] |
TÜV Rheinland
TÜVs (; short for , ) are internationally active, independent service companies from Germany and Austria that test, inspect and certify technical systems, facilities and objects of all kinds in order to minimize hazards and prevent damages. The TÜV companies are organized into three large holding companies, TÜV Nord, TÜV Rheinland and TÜV SÜD (with TÜV Hessen), along with the smaller independent companies TÜV Thüringen, TÜV Saarland and TÜV Austria. History With the increasing number and efficiency of steam engines during the Industrial Revolution, there had been more and more accidents caused by exploding (or more precisely, bursting) boilers. After the explosion of the boiler at the Mannheim Aktienbrauerei in January 1865, the idea was pursued there to subject boilers to regular inspections on a voluntary basis, as was already the case in Great Britain. Twenty boiler owners in Baden joined in the plans and finally founded the ''Gesellschaft zur Überwachung und Ver ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Poly Implant Prothèse
Poly Implant Prothèse (PIP) was a French company founded in 1991 that produced silicone gel breast implants. The company was preemptively liquidated in 2010 following the revelation that they had been illegally manufacturing and selling breast implants made from cheaper industrial-grade silicone since 2001 (instead of the mandated medical-grade silicone they had previously used). The hundreds of thousands of unapproved implants sold globally by PIP from 2001 to 2010 were found to have a 500% higher risk of rupturing or leaking than approved models, as well as being implicated in several deaths due to systemic toxicity and several cases of induced breast cancer. The scandal, which produced fears of a massive health disaster, prompted a full recall of the company's implants by the French health ministry in 2010, by which time the company was already defunct. History PIP was founded in 1991 by the Frenchman Jean-Claude Mas, born in 1939, a former butcher and later medical sal ... [...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 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 assura ... (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 marking for devices, common specifications, EUDAMED registration, and increased post-market surveillance activities. Classification The regulation introduces, in §47, th ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Market Surveillance
Market surveillance for products ensures that products on the market conform to applicable laws and regulations. This helps to foster trust among consumers buying products or financial services and protects consumers and professionals from harm from non-compliant products. It also helps companies that comply to stay in business and avoid losing market share to rogue traders. European Union In the European Union, individual member states are responsible for market surveillance but EU harmonisation legislation is considered necessary to guarantee the free movement of products within the Union,Eur-LexRegulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products had the effect of amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 published 25 June 2019, accessed 20 November 2020 and any action undertaken regarding product safety for consumer products and other precautions f ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
