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The Duties of European Authorized Representative

European Authorised Representative or European Authorized Representative refers to a company specifically designated by overseas manufacturers in the EEA (including EU and EFTA). The company must register formally according to company regulation in EU country. The company performs specific duties according to EU related instructions and laws.

1. To represent non-EU manufacturers dealing with the EU Authorities.

2. The European authorized representative preserve the technical files of latest, affix CE mark products and ensure timely provide them to EU authorities to review.

3. According to the vigilance system program established by non- EU manufacturers, the European authorized representative assist to carry out the accident report, recall, etc.

4. The new method instruction require European authorized representative must be located within the EEA and have business registration address (some countries require European authorized representative that must have company registration number or the EU VAT registration number) ；

5. Government and competent authority of members of the EEA can find the European authorized representative directly at any time to check whether outside manufacturer fulfills the duties required by related EU direction and law;

6. Although the European authorized representative may represent EEA overseas manufacturers to perform the specific duties that EU related instructions and laws required the manufacturer, but manufacturers still shoulder mainly responsibility.

7. The Article 14.2 of 93/42/EEC medical device directive altered from 2007/47/EC rules that non-EU manufacturers must specifically designate only one European authorized representative. It means that manufacturers can not confuse the general business representative (dealer, importer, etc) with European authorized representative;

8. Without the consent of the manufacturer, the European authorized representative cannot change products produced by EU foreign manufacturers alone, even to make the offending products comply with the EU product instruction requirement.

9. Lotus Global is a formal company set up according to EU andEnglandregulations, it is located in London and provides professionally European authorized representative service. It can reduce intermediate link for customers, save time and fee and make the process of your products going into market simplification in the condition of meeting the current EU regulations.

10. In the same time Lotus Global can provide clients timely information communication and assistance to solve when products has any problems sold within EU.

Note:

1. Solo person has no business license of formal company can not be European authorized representative!

2. Avoid letting relatives and friends studying or working part-time in EU to be European authorized representative!