欧洲授权代表常见问题解答医疗设备立法规定了欧洲授权代表的作用，也称为欧盟Auth。众议员，EC代表或AR，适用于在欧洲没有自己制造地点的制造商。欧盟授权代表代表制造商采取行动，以承担与主管当局的沟通。根据《医疗设备法规》（EU）2017/745（MDR）和体外诊断医疗设备调节（EU）2017/746（IVDR），The欧洲授权代表is assigned a narrowly defined role with the belonging obligations.
欧洲授权代表常见问题解答
欧洲授权代表
A European Authorized Representative (E.A.R.) serves as a legal entity designated by non-European Union (EU) manufacturers, to represent them in the EU and ensure their compliance with the European Directives.授权代表应作为与欧盟成员国主管当局的联系点。医疗设备调节（MDR）和体外诊断医疗设备调节（[调节_（EU）_2017/746]）在医疗设备监视领域增加了E.A.R的义务。
- We serve our clients by providingturnkey services，系统实施，培训，许可，监管部门批准和认证。
- 操纵子将为您提供有关医疗设备的市场分析和可行性以及完整产品开发过程的完整指导。
欧洲授权代表for Medical Device
医疗器械是否需要通知的身体(in the case of Class I sterile/measuring/ resusable or IIa, IIb, III) in order to obtain the CE Marking or is permitted to self-declare (Class I non-sterile, non-measuring), non-EU based manufacturers are legally obligated to appoint an Authorized Representative in order for their products to legally circulate within the EU Market.
EU Authorized representative services
A European Authorized Representative may also be known as a EUAR, EC REP, CE REP, EU REP and also an EAR. All of these mean the same; EU Authorized Representative.您的欧洲授权代表（EC REP）提供了您（非欧洲医疗设备制造商）国家主管当局（卫生部）和通知机构之间的联系点。
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欧盟授权代表职责
- 在产品包装上提到的欧盟中提供注册地址；
- Keep the updated EU DOC, the Technical Documentation, and certificates permanently available at the registered address for inspection by the competent authorities;
- Maintain constant availability to represent the manufacturer in front of the European Commission, EU authorities, EU NB’s and the EU users;
- Complete applications on behalf of the manufacturer for Device registration and EU Free Sale Certificates etc.;
- 照顾医疗保健专业人员，患者和用户报告的任何事件（警惕性报告），并立即通知制造商；
- Safeguard the compliance with regulatory news and updates;
- 检查进口商，制造商，产品以及欧盟的注册。需要检查这些已更新；
- 咨询并不断支持制造商；
- 如果制造商的行动违反了欧盟MDR/IVDR中规定的义务，则终止了授权。
- 终止授权的日期和即将到来的E.A.R授权的开始日期；
- 可以在制造商提供的信息中指定的欧洲授权代表之前的日期，包括任何促销材料；
- 文档的手部，包括机密性方面和财产权；
- The responsibilities of the departing EC Rep after the end of the mandate to forward to the manufacturer or incoming EC Rep regarding any complaints or reports from healthcare professionals and users about suspected incidents or adverse events related to a medical device/IVD for which it had been designated as the EC Rep.
欧洲授权代表requirements
To become an EU Authorized Representative of a company there are 2 main obligations:Being a natural or legal person established in the European Economic Area (EEA), European Union (EU) & European Free Trade Association (EFTA).You should be explicitly designated (Authorized) by a non-European manufacturer with a written mandateAnd most importantly you should accept to be the Representative of this company.
欧洲授权代表必须与制造商建立关系，并且必须以制造商与AR之间的任务授权记录该关系的条款。监视和遵守欧洲法规可能具有挑战性。为您的医疗设备或IVD公司选择授权代表是一个认真的决定，这将影响您多年。仔细考虑上述要点 - 您的需求，他们的经验，公司的历史以及任命分销商的问题 - 将帮助您为公司做出最佳决定。