1. What is EU registration?
EU registration refers to the registration of medical devices with the competent authorities of EU member states before entering the market. The registration includes economic operator (manufacturer, authorized representative or importer) registration and device registration.
2. Who needs EU registration?
According to Article 31 of the MDR (EU 2017/745), medical device manufacturers, authorized representatives and importers need to register with the competent authorities of EU member states before they can enter the market. Manufacturers can register directly by themselves or through their authorized representatives. In addition, after the registration, the confirmation information shall be updated annually.
3. Who is the authorized representative?
An authorized representative refers to any natural or legal person identified in the EU, who has received and accepted the written authorization from a manufacturer located outside the EU, and represents all actions performed by the manufacturer in accordance with the obligations required by the regulations for the manufacturer. The manufacturers/traders outside the EU must appoint their authorized representatives located in the EU.
4. Where to register?
The current registration is completed through the system of the competent authority of each EU member state, and will be linked from the competent authority to the EUDAMED2 database, but the current EUDAMED2 database is not open to the public. The EU is currently developing the EUDAMED database, which is expected to be launched in December 2020, when the registration information will be made available to the public.
In view of the Brexit, the medical device regulatory systems of the UK and the EU will operate independently. Therefore, the EU registration is not a substitute for the UK registration. For the enterprises that have customers in the UK and other EU member states, they need to appoint an EU authorized representative and a UK representative to complete the EU registration and the UK registration respectively.
5. What materials need to be submitted for the EU registration?
1)Type of economic operator (manufacturer, authorized representative or importer)
2)Name, address and contact information
3)If the materials are submitted by an agent, the name, address and contact information of the agent shall also be provided
4)Name, address and contact information of the person responsible for the regulatory compliance
1） Device name
2） Intended use
3） Basic UDI-DI
4） Certificate with the No. issued by the notified body, where applicable
5） Risk level of the device
6） Declaration of conformity
7） Instructions for Use
8） Other information that needs to be confirmed, such as whether it is disposable, whether it contains human blood or plasma, and whether it contains animal origin
6. As a global technical service provider that is professional in the field of medical device regulations, SUNGO can provide the following services:
1） Services as an EU authorized representative: SUNGO has many branches in Europe, so it can act as your authorized representative to perform the specific duties required by relevant EU laws and regulations.
2） Registration in the Netherlands (CIBG): help the medical device enterprises submit relevant information to the CIBG registration system in the Netherlands, where a registration letter will be issued after approval. The approval period is about 1~2 weeks.
3） Registration in Germany (BMG): help the medical device enterprises submit relevant information to the BMG registration system in Germany, where a registration letter will be issued after approval. The approval period is about 3~4 months.
4） Registration in the UK (MHRA): help the medical device enterprises submit relevant information to the MHRA registration system in the UK, where a registration letter will be issued after approval. The approval period is about 1~2 months.
7. SUNGO service process:
1） Sign the contract and fill in the application form
2） Provide the technical documentation that meets the requirements of the EU regulations, including the CE certificates if necessary
3） After the documents meet the requirements, sign the EU Authorized Representative Agreement
4） Submit the materials required for the registration, usually including the product’s declaration of conformity, CE certificate (where applicable), instructions for use, labels and test reports (required in the UK)
5） Submit the documents and registration application to the competent authority by the European Authorized Representative
6） Pay the registration fee (applicable in the UK)
7） Review and approve the registration materials by the competent authority
8） Obtain the registration approval letter and deliver it to the customer