European Medical Device Regulations

European Medical Device Regulations Practical Application Project The intent of the proposed revisions to the existing European Medical Device Directives is to better protect public health, ensure free and fair trade of goods, and adapt the legislation to the technological advancements observed throughout the industry.1 These revisions have been in process since 2008, when the EU Commission initiated a public forum to collect comments on the existing European medical device directives.TUV In 2010, the need for change was even more apparent with the discovery of the French PIP breast implant scandal. Emergo In 2012, the European Commission released the initial draft of the proposed regulations. The directive on active implantable medical devices (90/383/EEC) and on medical devices (93/42/EEC) was combined into one proposed regulation on medical devices, referred to as MDR. A proposed regulation on in-vitro diagnostic (IVD) medical devices, referred to as IVDR, is intended to replace the existing directive (98/79/EC). The European Parliament and the European Council amended the proposed regulations, and final texts were released in June 2016.1 The regulatory approach utilized in the MDR and the IVDR is a life-cycle approach, rather than pre-approval path as outlined in the existing directives. Guidance documentation related to Authorized Representation, Clinical Evaluation, Vigilance, and Post-Market Clinical Follow-Up were essentially incorporated into the regulations. The major changes included in the final texts of the MDR and IVDR are described below and the subsequent affects on manufacturers, notified bodies, regulatory agencies and patients are outlined. Scope Expansion The MDR and IVDR include a revised medical device definition, which broadens the application of the regulation to include products not currently covered under the existing directives. For example, the MDR will apply to products used for cleaning, disinfection or sterilization. Under the current directive, these types of products were considered accessories to medical devices and thus were out of the scope of the Directive.Emergo Other product groups now within scope of both the MDR and IVDR include devices that do not have a medical intended purpose, such as colored contact lenses, cosmetic implant material, lifestyle and nutritional diagnostic tests. TUV, BSI MDR/IVDR The definition of a medical device accessory was also revised, to include products that assist devices, which will cover additional products. Classification rules in MDR and IVDR changed as well. The MDR increased classification for some devices or requires heightened oversight by the Notified Body but did not change the actual classification of the device. Rather than utilizing the list-based classification system in the Directive, IVDs will be classified per the system developed by the Global Harmonization Task Force into four risk-based classes using seven distinct rules. For IVD devices that do not fit into the classification rules and were self-certified under the existing Directive, the IVDR will classify these devices into a higher risk class which will require Notified Body certification. This is a pivotal shift for the IVD industry since approximately 80-90% of IVDs will now require Notified Body certification to sell in the EU.BSI MDR/IVDR Placing Products on the Market The number of Essential Requirements increased, as well as the number of detail for each requirement. The concept of common specifications was added to the MDR. Referred to as common technical specifications in the IVD Directive, common specifications are documents (not standards) that describe technical or clinical requirements and provide a method of conformity to a requirement of the Regulation. Manufacturers are generally required to comply with common specifications, unless justification can be adequately demonstrated to ensure the same level of safety and performance. The regulations require common specification compliance for aesthetic products. Clinical Evaluation Clinical Investigation The requirements for clinical evaluation and clinical investigation are more rigorous under the new regulations. Clinical investigations may be required for class III and implantable devices if the existing clinical evidence does not fulfill the new requirements. Clinical performance studies will be required and significantly more evidence will be required for IVDs.BSI IVDR Both the MDR and IVDR control the conduct of interventional and other clinical performance studies and require the use of good clinical practices, including informed consent. Another major change is the Post-Market Clinical Follow-up requirement as part of the clinical evaluation cycle for the device. For clinical evidence that relies on equivalence with another predicate device, there are several additional requirements that will likely limit the path to market for this type of clinical justification. In order to leverage equivalence to another device the manufacturer must scientifically justify technical, biological and clinical similarity. There needs to be no significant difference in the clinical performance and safety of the device and the predicate. The manufacturer must be able to demonstrate access to the data on the predicate device in order to substantiate this claim. Since that data is typically proprietary between market competitors, this requirement will likely severely limit the use of comparator equivalence justifications. Supply Chain Enhancements Both the MDR and the IVDR implement new supply chain requirements that affect each step of the medical device supply chain. Each supply chain participant, including importers and distributors, will be responsible for verifying regulatory compliance. Better definition on roles and responsibilities is defined between the authorized representative, distributor and importer. Vigilance reporting of adverse events and subsequent implementation of corrective action (as required) will be expanded to include importers and distributors as well as the manufacturer. All members of the supply chain must be able to maintain traceability of devices and retain those records for at least five years after the last device is supplied to the EU market. The regulations define the financial liability of the manufacturer as well as the authorized representative in the case of injury caused by the device. Labeling Unique device identification (UDI) will also be required. The UDI is compromised of two parts, a device identifier(DI) and a production identifier (PI). The DI is a fixed portion of the UDI that identifies the model number of the device and links the device to the manufacturer. The PI is the variable portion of the UDI that identifies the lot/batch number, expiration date/manufacturing date or serial number for the device. There are many changes to labeling and instructions for use requirements. All device labels, on all levels of packaging will likely be revised as a result of the new regulations. There are special labeling requirements for certain implant products. The patient must have easy access to all safety information, including warnings and precautions, expected lifetime of the device and any mandatory follow-up. With regards to the actual implanted device, the patient must receive identification of the device including UDI information. Vigilance and Post Market Surveillance There are substantial changes to the post-market surveillance and vigilance reporting requirements under the new regulations. Some reporting rules were changed, which will result in more reports. The timeline for reporting serious public health threats did not change, but the timeline for reporting all other adverse events decreased from 30 days to 15 days. The reduced time allowed for reporting will likely result in an increase in the number of follow-up reports in order to provide additional information. The combination of the change to reporting rules and the reporting timeline shift will result in an overall increase in the number of vigilance reports submitted by manufacturers. A requirement for post-market clinical follow up was added as well as periodic (annual) safety update reports. These reports will summarize post-market data and analysis, a description of any actions taken as a result of post market trends and include sales volume data. The Affect on Key Stakeholders Manufacturers There is no provision for grandfathering of existing products under the new regulations. Therefore device manufacturers will need to review product portfolios to determine the affect of the new regulations and subsequent actions needed for both CE marked products and non-CE marked products. BSI MDR/IVDR Due to the increased clinical and regulatory requirements, manufacturers may need to invest in additional resources to adequately satisfy the clinical and regulatory requirements. It is possible that new clinical data will need to be generated, which is a substantial undertaking, both from an economic and resource perspective. Under the new regulations, device manufacturers (and authorized representatives) are required to retain at least one person permanently and continuously who is responsible for regulatory compliance, regardless of the size of the organization. The one exception noted for this is for manufacturers of custom devices who are micro-enterprises. Notified Bodies One of the major role changes driven by the new regulations is the evolution of the notified body role from an industry partner under the Directives to a police-like extension of the Competent Authorities. In the new regulations, notified bodies are required to undergo a designation process and stricter requirements for notified body staff are defined. The demand for notified bodies will increase dramatically, as not all current notified bodies may seek or may not seek full designation for all services currently supplied to manufacturers. Further increasing the demand for notified bodies, is the classification changes, especially in the IVDR, which will require more resources from designated notified bodies. Another major change in the MDR is that notified bodies will be required to submit their clinical evaluation assessment report to an expert panel appointed by the EU Commission prior to certifying a class III implantable device or class IIb device intended to intended to administer/remove a medical product. The regulations will require notified bodies to conduct unannounced audits at least once every five years, which originated as a recommendation from the commission in 2013. Notified bodies are required to test manufacturing samples, or even market samples. However, the responsibility for the cost of this testing is not defined. Regulatory Agencies In an attempt to harmonize efforts between member states, a new regulatory body called the Medical Device Coordination Group (MDCG) is defined with a primary purpose of increasing collaboration between member states while allowing the EU Commission to act when required. The additional vigilance requirements will demand more resources to support processing data at the member state level. Member states will be need to work together in order to coordinate enforcement activities and report surveillance plans to be incorporated into the European Market Surveillance Plan. Member states also can begin applying fees to cover the costs associated with the new requirements. Patients One of the primary objectives of the new EU regulations is to better protect public health. Patient access to information is enhanced. The addition of UDI and vigilance reporting to the European database systems will help make essential device information and user experience data more readily available. UDI information will improve recall and field safety corrective action effectiveness. Additional labeling requirements will better inform the end user. One drawback is that due to the tightened clinical requirements, patients may experience a longer delay in access to new medical devices and technologies. However, more robust regulatory controls with the intent to improve overall patient safety should outweigh this risk. The changes the new regulations bring to the European medical device community and vast. Although the new regulations will not go into effect until three years after formal publication in the Official Journal of the European Union (OJEU), it is important to begin preparing now for implementation. References: http://europa.eu/rapid/press-release_IP-12-1011_en.htm Medtecheurope, European Unique Device Identification Database (EUDID), Accessed February 29, 2017 http://www.medtecheurope.org/sites/default/files/14_MedTech%20Europe_Background%20Paper_EU%20UDI%20Database_PUBLISHED.pdf EU Commission Recommendation. n.d. https://www.3ec.sk/fileadmin/user_upload/Product_Certification/UNANNOUNCED_AUDITS_2014.pdf.2. Commission Recommendation. September 2013, 2013. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2013:253:0027:0035:EN:PDF.

Macbeth: a Dead Butcher

Parker Durham Far From a Dead Butcher â€Å"Producing forth the cruel ministers of this dead butcher and his fiend-like queen†¦Ã¢â‚¬  Malcolm spoke these words in the closing lines of the play shortly after Macbeth was killed by Macduff. While it is true that Macbeth could be characterized as a â€Å"dead butcher,† I do not believe those two words do justice in describing the person Macbeth truly is. While Macbeth commits atrocious acts of violence and murder, he did not do so without feeling regret and remorse.In Act II, Scene II, we see how Macbeth regrets slaying his king almost immediately after he pulls his dagger from Duncan’s body. Macbeth tells Lady Macbeth that so great was his guilt that he could not utter â€Å"amen† when he heard â€Å"God bless us† come from a nearby room. As humans, we all make mistakes. Usually, a single or even multiple mistakes do not define our lives. However, in Macbeth’s case, his mistake was so severe tha t it would ultimately lead to the loss of everything he loved.Killing Duncan would nullify all the good things Macbeth accomplished in his lifetime. Instead of being remembered as the valiant leader he was, he was remembered as a murderous fiend. One committing an act as foul as Macbeth’s would make one’s peers quickly forget about all of that person’s previous accomplishments and honors. In the beginning of the play, Macbeth is respected and revered by his fellow officers and countrymen.So great were his accomplishments in the Scottish war against Norway that King Duncan awarded Macbeth the title of the Thane of Cawdor (Act I Scene II). After this appointment, Macbeth held the titles of both Thane of Cawdor and Thane of Glamis. He was the most noble of all the noble, so much that the king himself visited his home. He forfeited all of this due to his moral ambivalence and greed. Ambition is a good character trait to possess. However, Macbeth’s ambition wa s so unbridled that it caused him to lose his peace of mind, his friends, and his honor.Macbeth had everything men envy and was far from a â€Å"dead butcher,† but due to one decision, his whole reputation and character were tarnished. Macbeth himself said it best in Act V, Scene III, when he said, â€Å"Is fall’n into the sear, the yellow leaf; and that which should accompany old age, as honour, love, obedience, troops of friends, I must not look to have; but, in their stead, curses, not loud but deep, mouth-honour, breath, which the poor hear would fain deny, and dare not. †

The Attack On Pearl Harbor And 2001 Attacks On The World...

The United States (U.S) Intelligence community has come a long way since the revolutionary war. After winning independence from England, the U.S would not invest much into intelligence or foreign policy until the 20th century. Foreign policy was simply not a priority for our young nation, having an ocean on eastern and Western boarders of the country severely limited potential threats. President Franklin D. Roosevelt would be the first president since Washington to understand the importance of intelligence and lay the groundwork for what we now consider national intelligence. Unfortunately, it has taken two catastrophic failures in intelligence for the U.S to realize the need for good intelligence and take steps to improve itself. The†¦show more content†¦Unfortunately, due to the fractured state of U.S intelligence community, that was never a possibility. This major intelligence failure was a wakeup call, and the goal of the U.S intelligence community was now to prevent ano ther such attack from happening. Cold War Intelligence The Cold War with the Soviet Union and its allies started almost immediately after the end of WWII, and would be the next step for the U.S intelligence community. The signing of the National Security Act of 1947 by president Truman drastically restructured the military and intelligence community, creating the Department of Defense (DoD) and Central Intelligence Agency (CIA) while establishing a clear chain of command (CIA, 2008). With the establishment of the CIA and director of central intelligence, The National Security Act of 1947 the U.S had a permanent and legitimized intelligence community, one that could start to develop and refine their own methods of operation and traditions (Lowenthal, 2017). The National Security Act of 1947 would go largely unchanged for 57 years, not being severely altered until 2004. After Pearl Harbor the intelligence communities primary function was to ensure that a catastrophe of that scale woul d not occur again. During the cold war, the largest threat to the U.S was a nuclear war with the Soviet Union, so an extremely large percentage of intelligence assets were focused on observing the Soviet nuclear program (Bukharin,Show MoreRelatedA Comparison of the September 11 Attack and the Attack on Pearl Harbor742 Words   |  3 PagesSeptember 11th 2001 On Sept. 11, 2001, A date that will live in infamy for Americans, terrorists attacked the World Trade Center in New York City. At 8:48 a.m. flight 11 crashed into the north tower. As it continued to burn a second plane flight 175 carrying 65 people crashed into the south tower around 9:05 a.m.. as smoke and debris fill the air in New York City after one of the World Trade Center towers collapsed. 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The documentary ‘Taken for a Ride’, Corporate Capitalism, urban transportation and General Motors consumer preference manipulation

The documentary ‘Taken for a Ride’, Corporate Capitalism, urban transportation and General Motors consumer preference manipulation Introduction Capitalism entails an economic system in which the private players have permission to control and own property in agreement with their own will and interests, and the demand and supply forces coordinate the pricing of the products in the market. The actors in this system aim to maximize their profits. The role of government is reduced to maintaining justice, fair taxes, and peace, and the market is free and competitive. Corporate capitalism is where orderly and specialized corporations dominate the free marketplace. These corporations operate to make their own profit, and not in the interest of the public. This paper will utilize â€Å"Taken for a Ride’ documentary in evaluating how the General Motors strived to build their own business at the expense of the consumer preferences and technologies. The paper will then analyze the effects of such actions, and what can be done about them and by whom. General Motors manipulated consumer preferences and technologies for profit ‘Taken for a Ride’ documentary was aired in many public televisions in 1996. The documentary describes how the electric streetcars went to extinction and exposed the main player to that effect. It explained how the General Motors (GM) contributed to the demise of the street cars. Previously, the documentary argues that America’s cities were ruled by streetcars that were clean, comfortable, and smooth. They offered transport services that the consumers enjoyed. Nonetheless, General Motors conspired to see these cars out of the public transport market. ‘What is good for General Motors is good for America,’ was a famous GM’s slogan that seemed to suggest that GM could make choices for everyone in America. As it happened, GM made the choice to eliminate the streetcars, and hence dominate the public transport market. It didn’t matter to the company whether the consumer population was comfortable with the technology or not, as long the company ’s profit margins would increase. After their introduction in 1988, the streetcars were quite efficient in their services. Their usage increased, with only a few towns lacking a streetcar system. The fast growth of urban population, low fares charged, and increasing incomes were factors that promoted the use of streetcars. About 65 million US dollars were lost by GM in 1921. This convinced the company that the only way that the company’s profit and sales could be increased was by eliminating electric streetcars. The company took several measures to ensure that their main competitor was out of the business. GM Company set up subsidiaries, for example, National City Lines that would purchase rails all over the country, hence dismantling the streetcar system of transport. The company started by gaining interests in the New Work railways, and after a short while, the rails was destroyed, and the city motorized. Also, GM made streetcar companies convert to buses by threatening to divert profitable automobile cargo to opponent carriers. Additionally, the officials of GM bribed the bank officials to persuade their rail customers to switch to motor vehicles. In case GM was not able to buy the rails, the official of the rail companies were bought by GM. The overall effect wall a weaken streetcar transport system. In fact, GM had acquired more than 1000 electric railways and had switched 90% of them by 1950. GM and National Transport Lines were at a point convicted for their attempt to monopolize the transport sector. They were fined, but the fact that GM had already dominated the market, and electric streetcar system was becoming extinct, still remained. The buses introduced by GM were of poor quality and slow, with a bad smell. Hence, an excellent transport system was replaced by a bad one. The situation was monopolistic, and GM enjoyed increased sale and higher profit margins. The consumers, however, had to put up with a technology that they didn’t fully like. Veblenian dichotomy argues that institutions or firms decide what consumers will use, and GM exactly did that. Effects of companies attempting to monopolize/ how I feel about these types of corporate actions The economy of the world is dominated by giant corporations. These companies are so large and developed that they tend to eliminate the smaller industries. These types of corporations are based in capitalist countries. Monopoly capitalism comes with both benefits and harm effects. The corporations that practice this behavior have higher levels of capital. They get involved in mass production of goods and services and therefore enjoy economies of scale. They purchase raw materials for production in large quantities and cheaply. Their overall cost of production becomes low, and this reduces the prices charged on the finished goods. They hire specialists, and this action enhances the quality of their goods or services. The neoclassical economics approach suggests that individuals will tend to maximize the utility of their money. The consumers will, therefore, go for high-quality goods or services that are being sold at fair prices. Another assumption of neoclassical economics is profit maximization by firms. This forms the basis of the harmful effects of monopoly capitalism. For example, GM idea was to monopolize the entire public transport market and hence upgrade their sales and profits. It did not matter which method they used to eliminate the competitors, or how the consumers will be affected. Their only concern was to maximize their profits. It, therefore, means that dubious means may be used by large corporate organizations to kill small competitors. Again, the consumers’ interests are not taken into account, and there is a possibility of the services being of poor quality and also charged highly. Countering the harm effects of monopoly capitalism: What I believe should be done on these corporate actions The governments of capitalist countries have roles to play in protecting small companies as well as consumers from being misused by large corporations. The prices should be regulated as well as the quality of finished goods and services. This ensures that the consumers are not overcharged or subjected to lower quality products. The government also should regulate the formation of mergers that are likely to create an overly dominative company. Constant investigation to ensure that the power of monopoly is not being misused by the monopolistic companies can be effective in protecting the small companies and the consumers. Conclusion Large corporate organizations have higher levels of capital and can sometimes use their power and influence to illegally eliminate competitors from the market, as in the case of GM. This might, in some cases, lead to the production of low-quality goods or services. It is the role of the government to ensure that the small companies and consumers are protected from the large corporations.