About EU authorized representative

1. European authorized representative refers to a natural person or legal person explicitly designated by the manufacturer located outside the EEA (including EU and EFTA). The natural person or legal person can perform the specific duties required by relevant EU directives and laws on behalf of the manufacturer outside EEA.

2. When the products of exporters outside the EU encounter any problems in the customs clearance, the European representative will help the exporters to communicate with the customs and solve the problems, and the customs will usually ask for communication with the European representative of the exporters. When the exporter's products in the EU sales process in any problem, is also the European representative to help solve the problem. Therefore, the European Agency bears certain risks. The higher the risk of the products exported by exporters, the higher the risk of the European agency.

3. EU customers require overseas exporters to provide information on behalf of the European Union. On the one hand, it is to ensure the quality of products and the reputation of exporters; on the other hand, it is to facilitate subsequent communication.

4. In addition, EU representatives are required to apply for CE certification of medical devices. EU representatives are also required to apply for the EU free sale certificate.

In the countdown to the gradual entry into force of MDR and ivdr, the responsibilities of each business entity are further clarified with the regulations. In the new regulation, the responsibility of the EU authorized representative is strengthened. "The legal responsibility of the authorized representative does not affect the provisions of directive 85 / 374 / EEC, and the authorized representative is responsible for the product quality, just like the manufacturer." Therefore, it is very necessary to select a good and standardized EU authorized representative and cooperate with the European representative to complete the good communication and declaration with the competent authorities. After the implementation of the new regulations, odel can no longer be as simple as a single address. It has its own responsibilities and obligations, mainly including the following aspects:

1. Provide the registered address in EU for reference on product packaging;

2. Keep the updated EU doc, technical documents and certificates permanently provided at the registered address for inspection by the competent authorities;

3. Maintain continuous availability in front of the European Commission, EU authorities, EU Nb and EU users, representing manufacturers;

4. Fill in the application for equipment registration and EU free sales certificate on behalf of the manufacturer;

5. Handle any incident (alert report) reported by medical staff, patients and users, and inform the manufacturer immediately;

6. Maintain compliance news and updates;

7. Check the registration of importers, manufacturers and products, as well as the registration of EU. You need to check for these updates:

8. Consult and continue to support manufacturers:

9. If the manufacturer violates the obligations stipulated in EU MDR / ivdr, the authorization will be terminated

Generally speaking, there are two types of enterprises that need EU authorized representatives in the medical device industry:

1) Production entity enterprise;

2) It is a trade oriented enterprise.

According to the nature of different types of enterprises, there are different European prices, which need to be discussed according to different products.

As a legal company registered in the European Union, biodomi GmbH is located in the heart of European medical device industry - Frankfurt, Germany. We have professional technicians who are familiar with relevant EU laws and regulations, have close contact with local government agencies, and provide customers with EU authorized representative, free sales certificate and other related services. Baioda can reduce the intermediate links in the service process, provide you with timely information communication in case of any situation when you sell products in the EU, and help you solve the problems. Simplify the procedure for your products to enter the market in accordance with current European regulations.