Using an authorised representative in the EU - duties and liabilities

Mathias Klumper; Pascal Hofer

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Using an authorised representative in the EU - duties and liabilities

机译：在欧盟使用授权代表-责任和义务

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EU legislation governing a manufacturer's use of an authorised representative and the obligations and liabilities of each party appears to be very misunderstood. The Medical Devices Directive (93/42/EC), as amended by Directive 2007/47/EC, requires that non-EU manufacturers designate an authorised representative in the EU to represent them there, Competent authorities, however; vary in how they interpret the MDD rules on the matter In addition, there is confusion regarding the responsibilities and accountabilities of both manufacturer and authorised representative. This article clarifies the EU requirements and provides manufacturers with practical advice on how best to draft a contract with an authorised representative.

机译：欧盟关于制造商使用授权代表的法律以及各方的义务和责任似乎被误解了。经指令2007/47 / EC修订的医疗器械指令（93/42 / EC）要求非欧盟制造商在欧盟指定一名授权代表在欧洲代表他们（主管当局）;他们在此问题上对MDD规则的解释方式各不相同。此外，制造商和授权代表的责任和问责制也令人困惑。本文阐明了欧盟的要求，并为制造商提供了有关如何最好地与授权代表起草合同的实用建议。

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《Regulatory Affairs Journal- Devices》 |2011年第maraaapra期|共4页
作者
Mathias Klumper; Pascal Hofer;
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正文语种 eng
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1. Using an authorised representative in the EU - duties and liabilities [J] . Mathias Klumper, Pascal Hofer Regulatory Affairs Journal- Devices . 2011,第MaraaApra期

机译：在欧盟使用授权代表-责任和义务
2. Informal harmonisation of EU authorised representative role is recipe for confusion [J] . Ashley Yeo Scrip Regulatory Affairs . 2012,第Apra期

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3. Study protocol for a transversal study to develop a screening model for excessive gambling behaviours on a representative sample of users of French authorised gambling websites [J] . Jean-Benoit Hardouin, Jean-Michel Costes, Marie Grall-Bronnec, BMJ Open . 2017,第5期

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4. DUTIES AND LIABILITIES OF SPACE TOURIST OPERATORS [C] . Niamh OBrien . 2007

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5. Estimating fuel use and emission rates of nonroad diesel construction equipment performing representative duty cycles. [D] . Lewis, Michael Phil. 2009

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6. Study protocol for a transversal study to develop a screening model for excessive gambling behaviours on a representative sample of users of French authorised gambling websites [O] . Bastien Perrot, Jean-Benoit Hardouin, Jean-Michel Costes, 2017

机译：用于在法国授权赌博网站的代表性用户样本上开发针对过度赌博行为的筛选模型的横向研究的研究方案
7. Report from the Commission to the Council and the European Parliament under Article 8(6) of Council Directive 92/81/EEC, on the situation with regard to the exemptions or reductions for specific policy considerations as set out in Article 8(4) of Directive 92/81 and concerning the obligatory exemption of mineral oils used as fuel for the purpose of air navigation other than private pleasure flying and the exemptions or reductions possible for navigation on inland waterways other than for private pleasure craft as set out in Articles 8(1)(b) and 8(2)(b) of the same Directive. Proposal for a Council Decision authorising Member States to continue to apply to certain mineral oils, when used for specific purposes, existing reduced rates of excise duty or exemptions from excise duty, in accordance with the procedure provided for in Article 8(4) of Directive 92/81/EEC. COM (96) 549 final, 14 November 1996 [O] . 1996

机译：委员会根据理事会指令92/81 / EEC第8（6）条向理事会和欧洲议会提交的报告，内容涉及第8（4）条规定的特定政策考虑因素的豁免或减少情况。第92/81号指令，关于强制豁免用作私人飞行以外的空中航行燃料的矿物油，以及第8条规定的私人游艇以外的内陆水道航行的豁免或减少（同一指令的1）（b）和8（2）（b）。关于理事会决定的提案，授权成员国根据指令第8（4）条规定的程序，在用于特定目的时，继续适用某些矿物油，现有降低的消费税率或免征消费税。 81分之92/ EEC。投诉（96）549决赛，1996年11月14日

Using an authorised representative in the EU - duties and liabilities

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