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EC Rep: What is EEA/EU/EC European Authorized Representative (Authorised Representative)?

FAQ answered by Wellkang for Medical Devices CE marking (mark): What is EEA/EU/EC European Authorized Representative (Authorised Representative)?

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FAQ answered by Wellkang for Medical Devices CE marking (mark): What is EEA/EU/EC European Authorized Representative (Authorised Representative)?
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EC Rep: What is EEA/EU/EC European Authorized Representative (Authorised Representative)? | european.authorized-representative.eu Reviews

https://european.authorized-representative.eu

FAQ answered by Wellkang for Medical Devices CE marking (mark): What is EEA/EU/EC European Authorized Representative (Authorised Representative)?

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european.authorized-representative.eu european.authorized-representative.eu
1

CE 认证网:什么是欧盟授权代表(欧盟代表/歐體代表)?

http://european.authorized-representative.eu/european-authorized-representative_gb.html

必须将医疗器械, 体外诊断医疗器械(包括体外诊断试剂)信息 注册/通告欧盟主管机关. European Authorised Representative 或European Authorized Representative)是指由位于欧洲经济区 EEA(包括EU与EFTA). 欧盟授权代表在欧盟的产品指令(Directive)英文版里使用的标准术语为(英国式英语) European Authorised Representative, 因为需要指定欧盟授权代表的多数为位于欧盟境外的国家的制造商,尤其以美国的制造商为多, 美国的制造商更喜欢将欧盟授权代表以美式英语书写为: European Authorized Representative。 鉴于中文并非欧盟的官方语言,因此European Authorised Representative 并没有对应的中文的官方术语。 在中文的翻译里,通常将European Authorised Representative 或European Authorized Representative译为: 欧盟授权代表.

2

Why choose Wellkang? Unique benefits of choosing Wellkang as European (EEA/EU) Authorised/Authorized Representative!

http://european.authorized-representative.eu/why-choose-wellkang-your-benefits-by-appointing-wellkang-as-your-eu-authorized-representative.html

As of 21 March 2010. EEA/EU/EC European Authorised/Authorized Representative. Must be designated by a non-EEA manufacturer of medical devices as required by directive 2007/47/EC, are you ready? Medical Devices and IVD. In Vitro Diagnostic Medical. Other EEA authorities by world-leading CE Marking. Specialists based in London/UK. Click here to get FREE Guide. Be your European Authorised/Authorized Representative! Why do you need a European Authorised/Authorized Representative? How can Wellkang help you?

3

Why do you need a European Authorised/Authorized Representative?

http://european.authorized-representative.eu/why-do-you-need-a-european-authorized-representative.html

As of 21 March 2010. EEA/EU/EC European Authorised/Authorized Representative. Must be designated by a non-EEA manufacturer of medical devices as required by directive 2007/47/EC, are you ready? Medical Devices and IVD. In Vitro Diagnostic Medical. Other EEA authorities by world-leading CE Marking. Specialists based in London/UK. Click here to get FREE Guide. Why do you need a European Authorised/Authorized Representative? Why do you need a European Authorised/Authorized Representative? Then you will appr...

4

What is EEA/EU/EC European Authorized Representative (Authorised Representative)? FAQ answered by Wellkang

http://european.authorized-representative.eu/what-is-authorized-representative.html

As of 21 March 2010. EEA/EU/EC European Authorised/Authorized Representative. Must be designated by a non-EEA manufacturer of medical devices as required by directive 2007/47/EC, are you ready? Medical Devices and IVD. In Vitro Diagnostic Medical. Other EEA authorities by world-leading CE Marking. Specialists based in London/UK. Click here to get FREE Guide. As of 21 March 2010. EEA/EU/EC European Authorised Representative (Authorized Representative). Commercial representatives of the manufacturer (such ...

5

Disclaimer

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European Authorized Representative - mdi-europa

http://mdi-europa.com/european-authorized-representative

CE Consulting Medical Devices. AIMDD – Active Implantable Medical Devices Directive. MDD – Medical Device Directive. IVDD – In-Vitro Diagnostic Directive. OEM – Private Labeling. CE Consulting Electrical Equipment. EMC – Electromagnetic Compatibility. LVD – Low Voltage Directive. CE Consulting Environmental Requirements. WEEE – Waste Electrical and Electronic Equipment. RoHS – Restriction of use of Hazardous Substances. PPE Directive – Personal Protective Equipment. Partners & Associates. The manufacture...

creoquality.com creoquality.com

Guide to Medical Device Regulatory Classification - Creo Quality

http://creoquality.com/ask-cq/guide-to-medical-device-regulatory-classification

Catalyst. Connect. Create. Guide to Medical Device Regulatory Classification. Submitted by Jon Speer. Sun, 14/06/2015 - 6:40 pm. What I am about to share with you is a guide to medical device regulatory classification. In this guide, I will provide you with a step-by-step approach for determining how your medical device will be classifed by U.S. FDA, European Commision, and Health Canada. Basically, every medical device is regulated in some way by regulatory agencies, such as FDA. I know. Clear as mud.

ce-marking.org ce-marking.org

EC/European Authorized Representative for CE Marking

http://www.ce-marking.org/EU-representative.html

EC Authorised Representative for CE Marking - www.ce-marking.com Your browser doesn't appear to support frames - please click here. To view the site.

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EC Rep: What is EEA/EU/EC European Authorized Representative (Authorised Representative)?

As of 21 March 2010. EEA/EU/EC European Authorised/Authorized Representative. Must be designated by a non-EEA manufacturer of medical devices as required by directive 2007/47/EC, are you ready? Medical Devices and IVD. In Vitro Diagnostic Medical. Other EEA (EU/EFTA) authorities by world-leading CE Marking. Specialists based in London/UK. Click here to get FREE Guide. As of 21 March 2010. EEA/EU/EC European Authorised Representative (Authorized Representative). Commercial representatives of the manufactu...

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