Our Service: European Authorized Representative
We are your independent, confidential and authorized Representative in the EU, who:
Provides you with a name and address in the EU, which must later also be affixed to your devices. Makes notifications to the Competent Authority Maintains your technical documentation with a high. degree of confidentiality and makes the content available only to the Competent Authorities.
欧洲授权代表（欧盟授权代表或EAR）是指在欧洲经济区以外（包括欧盟和欧洲自由贸易联盟）设立的制造商明确指定的自然人或法人。此人代表制造商行事，并履行制造商在欧盟指令和法律中的义务。 新的《方法指令》要求设在欧洲经济区的欧盟代表必须有一个注册的商业地址。 为了检查制造商是否在国外履行义务，欧洲经济区成员国的主管当局可以在任何时候与其授权代表联系。 制造商的一般商业代理（如授权经销商），无论其所在地，都不应与欧盟授权代表相混淆。 虽然欧洲授权代表代表制造商接管了某些任务，但制造商仍然是主要责任方。
What does it mean?
- Current declaration of conformity and technical documentation
- Registration of class I products / low-risk products with a competent EU authority (if applicable)
- Keep the technical documentation available for the Competent Authority on request
- Enter the name and address of QuSmed on your devices, labels and product information
On your behalf, we act as an interface between the competent authorities, the Notified Body, the distributor and/or those responsible for regulatory affairs. This includes the processing of feedback within the EU.
制造商在欧盟市场上投放的带有CE标志的产品，必须按照法定的可追溯性要求，标明制造商的名称和地址。如果制造商来自欧洲经济区以外的国家(包括欧盟和欧洲自由贸易区)，产品还必须在标签上(铭牌或包装)标明欧盟代表的名称和地址。
- 为确保CE标志产品的技术档案(TCF)可供欧盟有关部门审查，外国制造商的欧盟代表将在最后一批产品出口后的10年内保存最新版本的TCF。
如果制造商的产品在欧盟以外的地方发生故障/事故/召回，欧盟授权代表必须与欧盟的主管部门联系、通知和沟通。
Which documents do we need?
Together we sign an agreement about the European representative.
This agreement is ongoing and is renewed annually.
- 选择一名合格、称职和专业的欧洲授权代表非常重要； 在欧盟注册的合法公司/拥有专业的技术人员，熟悉欧盟法规，能帮助厂家解决纠纷，可通过欧盟批准证书验证。
- 签署一份有效的欧盟代表协议，其中包括双方的姓名和地址，该协议随后也将出现在产品的标签上，以获得CE标志。
- 必须遵守下列规定： 欧盟授权代表的合同条件应以欧盟的主要官方语言书写。 应避免使用同时是欧盟授权代表的经销商。
What are the backgrounds?
The legal basis are all the three EU directives concerning medical devices, which includes the Medical Devices Directive (MDD 93/42/EEC amended by 2007/47/EC), the In Vitro Diagnostic Device Directive (IVDD 98/79/EC), and the Active Implantable Medical Devices Directive (AIMDD 90/385/EC). They require manufacturers or, their authorised representatives or others, that bring medical device(s) on the EEA market, to provide certain information to the Competent Authorities in the EEA Member State where they have a registered place of business.
These requirements have been transposed into national laws of the EEA Member States.
After the receipt of the notification/registration, the Competent Authorities shall process the data and inform the Commission of the European Communities and the other States Party to the Agreement on the European Economic Area, upon request.
欧盟对医疗器械和体外诊断的审批有明确而严格的要求（欧盟法规：医疗器械指令MDD 93/42/EEC和体外诊断医疗器械指令IVDD 98/79/EC），很容易概括为认证和注册。
对于Ix、IIa、IIb和III类医疗器械，产品必须经过欧盟批准的认证机构（NB）认证，然后颁发CE证书并附在产品上。
对于第一类产品，欧盟要求制造商根据欧盟指令和欧盟标准对产品进行评估和改进。然后申请CE标志，由制造商或其授权代表对产品进行注册，并提供相关产品信息。
欧洲经济区成员国的制造商可以自行注册并直接向主管部门报告。非欧洲经济区的制造商(如中国人)在加贴CE标志时，应指示其欧盟代表与欧盟代表所在国的主管部门联系，接管制造商的注册和产品信息，从而获得注册号。可以在欧洲经济区各成员国的主管部门进行注册，由主管部门将注册信息告知欧洲经济区各国，以避免重复注册。
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