EUDAMED registration process
Guide to EUDAMED registration process
EUDAMED (European Database on Medical Devices) is a centralized database designed to enhance transparency and ensure the safety of medical devices within the European Union (EU). In this blog post, we will discuss who should register in EUDAMED and provide a step-by-step guide on how to complete the registration process effectively.
Who Should Register?
EUDAMED registration is required for various economic operators involved in the medical device industry. These include:
1. Importers: Companies responsible for importing medical devices into the EU.
2. EU Manufacturers: Manufacturers of medical devices within the EU.
3. Non-EU Manufacturers: Manufacturers of medical devices located outside the EU.
4. System and Procedure Pack Producers: Producers of medical device systems and procedure packs.
5. Authorised Representatives: Representatives authorized by non-EU manufacturers to act on their behalf within the EU.
In addition to the above economic operators, other stakeholders such as Member States, notified bodies, and sponsors also need to enter relevant data into the EUDAMED database.
While EUDAMED registration is not currently mandatory, manufacturers are strongly encouraged to register themselves and their devices. Some Competent Authorities are even considering waiving the national notification obligation for devices registered in EUDAMED.
Mandatory Registration Timeline:
The registration of all devices will become mandatory within 24 months after the Commission publishes a notice confirming that EUDAMED is fully functional. In the case of incidents, mandatory registration may be required immediately.
How to Register?
EUDAMED consists of six different modules, of which the first three are currently active. Let's go through the registration process step by step in EUDAMED:
The first step is to register as an actor. Manufacturers should initiate this process by creating an account and providing accurate information about their company, including address, regulatory person details, and company identification information. After registration, the Authorised Representative will verify the information before it is validated by the Competent Authority. Manufacturers will receive a Single Registration Number (SRN) through this registration, which is necessary for the conformity assessment procedure conducted by notified bodies.
Alternatively, manufacturers can seek assistance from AF Pharma, an organization specializing in EUDAMED registration. AF Pharma can guide you through the registration process, ensuring fast validation and issuance of the SRN.
After completing the actor registration, manufacturers should proceed with device registration. The following steps should be followed:
Ensure that the devices comply with the applicable legislation (MDR/IVDR).
For non-EU manufacturers, sign a Mandate with the Authorised Representative.
Complete the actor registration as mentioned above.
Enter device information in the Device Module, following the user guide provided by the EU Commission.
The Authorised Representative must verify the UDI and Device information registration performed by the non-EU manufacturer in EUDAMED.
Registering in EUDAMED is a crucial step for economic operators in the medical device industry. It not only promotes transparency and safety but also helps streamline regulatory processes. By understanding who should register and following the step-by-step registration guide, manufacturers can ensure compliance with the requirements and take advantage of the benefits offered by EUDAMED. If needed, AF Pharma can provide expert assistance throughout the registration process, ensuring a smooth and efficient experience.The requirements for appointing an Authorized Representative are outlined in Article 11 of the MDR. Manufacturers must carefully select a qualified and experienced AR to ensure proper compliance with EU regulations and to navigate the complexities of placing medical devices on the EU market.