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1、wordText A / 509 Words / Time for reading: 3.5 minutes /The European mission said on Thursday it would toughen the regulation of medical devicesas a result of concerns raised by breast implants produced by the defunct French panyPIP, even as a scientifi c expert review it ordered concluded there was
2、 currently “insuffi cient evidencethat women using its products facedgreater health risks than others.John Dalli, health and consumer policy missioner, pledged to examine surveillance andoperation of the “notifi ed bodies that scrutinise medical devices across the EU in a current reviewof legislatio
3、n, stressing: “The capacity to detect and minimise the risk of fraud must be increased.His ments followed an offi cial report released on Wednesday in France that called for nationaland EU-wide co-operation including random inspections and sampling of medical devicesto prevent a repeat of the fraudu
4、lent use of substandard non-medical-grade silicone by PIP in implantssold to up to 400,000 women around the world.Xavier Bertrand, Frances minister of health, called for enhanced action in France and acrossEurope in the wake of the study, which highlighted that Afssaps, the French medical regulator,
5、did not inspect PIP from 2001 until a tip-off led offi cials to inspect and close down the panyin 2010. Jean-Claude Mas, its founder, is under police investigation for manslaughter.Mr. Bertrand has pledged to hire more health inspectors and undertake random checks onmedical device panies following g
6、rowing concerns over its regulatory system highlighted bythe widespread use of PIPs substandard breast implants.A French decision at the end of last year to offer all women free removal of PIP implants triggeredsimilar proposals in the UK, Germany and the Czech Republic and has helped spark a fresh
7、debate overtougher EU regulation of medical devices, which are subject to far less scrutiny than pharmaceuticals.However, a review released on Thursday by the EUs own Scientifi c mittee on Emergingand Newly Identifi ed Health Risks concluded: “Breast implants can fail, regardless of manufacturer,and
8、 the probability of failure increases with time since implantation. In most cases, breastimplant failure appears to be without identifi able health consequences for the patient with the exceptionof possible local plications.It stressed that limited data meant that while there was no link between bre
9、ast implants andcancer, there was a need for further work to understand the specifi c risks from the PIP products.Mr. Bertrand has endorsed calls for a parliamentary inquiry in France as well as a report fromthe countrys social affairs inspectorate, mirroring similar moves that led to tough new requ
10、irementsfor the pharmaceutical industry introduced last year in the wake of concerns about Serviersdrug Mediator.Medical device manufacturers have called for reforms to ensure that the national “notifi ed bodieswhich audit the quality of their products across Europe are of a consistently high standa
11、rd, while cautioningthat tough new regulatory requirements could harm the EUs petitive advantage.The French study showed that Afssaps had received multiple warnings over the relativelyhigh failure rate of PIP implants pared with those made by other panies, even though theoverall proportion remained
12、modest.From Financial Times, February 2, 20121. _ is the manufacturer of the breast implants under scrutiny.A. European mission B. PIP C. Afssaps 2. According to the passage, “notifi ed bodies in Paragraph 2 are responsible for _.A. proposing legislation, implementing decisions in European UnionB. p
13、roducing and marketing the medical devices across the EUC. providing some scientifi c advice to the European missionD. assessing whether a product meets certain preordained standards3. Which of the following statements is INCORRECT according to the passage?A. Women using the breast implants facedgre
14、ater health risks.B. The capacity to detect the risk of fraud should be increased.C. An offi cial report called for cooperation in France and in other parts of EU.D. Frances minister of health has pledged to hire more health inspectors.4. Which of the following countries have not all proposed to off
15、er women free removal ofPIP implants?A. France, Germany, UK B. Germany, UK, Czech C. US, Germany, Czech D. Germany, France, Czech5. Which of the following statements is true according to the passage?A. There is a consensus on the EU regulation of medical devices in the European Union.B. All breast i
16、mplant failure appears to be without identifi able health consequences.C. Tough new regulatory requirements could harm the EUs petitive advantage.D. The overall proportion of the implant failure is relatively high pared with others.答案解析：答案：1. B试题分析：此题为细节题。根据第一段“.breast implants produced by the defunct Frenchpany PIP可知B正确。答案：2. D试题分析：此题为语义题。根据第二段“.notified bodies that scrut
