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Questions for European Authorised Representative 

Q1: Can manufacturer located outside of the European Union have two EARs at the same time?

A: According to the latest version of Article 14 of the MDD: where a manufacturer who places a device on the market under his own name does not have a registered place of business in a Member State, he shall designed a single authorised representative in the European Union.

Per device, a single Authorized Representative has to be designated by the legal manufacturer which has not a registered place of business in a Member State.

Q2: What are duties and obligations of European authorized representative?

A: Represent the manufacturers to handle affairs with the Competent Authority.

The European authorized representative preserve the latest technical files for review by Competent Authority if required.

According to the Vigilance System Procedure established by manufacturers, the European authorized representative assist to carry out the investigation, recall the products.

Q3 Why need to find European authorized representative?

Answer: The manufacture outside the EU should be complied with the MDD as following: If products placing on the EU market should designate a European Authorised Representative, and its name and address should be clearly printed on the package, labeling and IFU.

Q4.Why do you need one European Authorised Representative?

Answer: To ensure the safety and conformity of EU regulation, the following requirements should be met:

1. Appoint European Authorized Representative:

2. European Authorized representatives must be printed in the packing:

The import products from the overseas with CE mark must print clearly the name and address of European authorized representative on the packaging, labels and instructions.

3."Technical documentation" must be stored in the European authorized representative office:

The European authorized representative office must preserve the latest technical documentation. According to the EU laws, it must ensure provide them at any time to EU for review if required.

After the last batch of products put into the market, the technical documentation should be reserved in the European authorized representative office for at least five years.

4. Help to solve any incidents announced by Competent Authority in EU

Q5. Why European Authorized Representative different from the importers or distributors of product?

Answer: The European authorized representative designated by manufacture, which is outside the EU, is responsible for regulation affairs with Competent Authority.

We strongly suggest that the manufacture should find a professional one, not a trading company or distributor which may know the skill how to increase the sales but know little about the complex regulations about the MDD.

So the trading or distributor can not catch the revised regulation information and transfer to the manufacture on time.

If the incident happened due to the distributor or the trading company, do you expect them will protect your company or theirs?

Q6. How to find good a European authorized representative?

Answer: You can not only on website for looking for European authorized representatives, if it’s nature has problems, no matter how large company the website looks, how detail the contents, they all make no sense.

Two steps can be taken to distinguish the good company or not:

First step-“search”: Search the address of European authorized representative on Google; whether there is some relationship with some illegal company (such as financial fraud company), and whether several companies are registered in one address. If one or two complied, that company must be use a virtual office address. Enterprise can never use such company!

Two measure-“call”: you can call the phone of European authorized representative in European working time (usually after 4 o 'clock afternoon in Beijing time), if no staff answer and instead of recording that means it is a recording telephone, there is no personnel in the office in Europe. Imagine if you cooperate with such company, when your products got some problems in the EU, how can you still find people to solve the problem?

We don’t want you to spend money and cooperate with a company which looks like to be a big company with many branches all over the world. But actually, it is just a very bad company with “virtual office”+ “recording telephone”!