EUDAMED REGISTRATION
As of my last update in January 2022, the European Database on Medical Devices (EUDAMED) serves as a central repository for information on medical devices within the European Union. However, registration with EUDAMED for medical devices is not directly done by manufacturers or other stakeholders. Instead, EUDAMED is primarily managed by the European Commission and national competent authorities.
The registration of medical devices with EUDAMED is typically part of the regulatory process overseen by notified bodies and competent authorities. Here's an overview of the steps involved in registering medical devices with EUDAMED:
Prepare Technical Documentation:
Before registering with EUDAMED, ensure that all necessary technical documentation for your medical device is complete and compliant with applicable European Union regulations, such as the Medical Device Regulation (MDR) or the In Vitro Diagnostic Regulation (IVDR).
Obtain CE Marking:
Ensure that your medical device has obtained CE marking, which indicates compliance with relevant EU regulations and standards.
Engage a Notified Body (if applicable):
For certain classes of medical devices under the MDR or IVDR, involvement of a notified body may be required for conformity assessment. Engage a notified body to conduct conformity assessment procedures, if necessary.
Register with Competent Authorities:
Register your medical device with the relevant national competent authorities of the European Union member states where you intend to market your device. Each member state may have its own registration requirements.
Upload Information to EUDAMED:
Once your medical device is registered with the national competent authorities, they will upload relevant information to EUDAMED on your behalf. This information includes details about the device, its manufacturer, authorized representatives, and certificates issued by notified bodies.
Access EUDAMED Database:
EUDAMED allows stakeholders, including manufacturers, notified bodies, competent authorities, and the European Commission, to access and retrieve relevant information on medical devices. You may access EUDAMED to verify the accuracy of the information uploaded and to ensure compliance with regulatory requirements.
Post-Market Surveillance Reporting:
Utilize EUDAMED for post-market surveillance reporting, including incidents, field safety corrective actions (FSCA), and periodic safety update reports (PSUR), as required by EU regulations.
Stay Informed:
Keep abreast of updates and developments related to EUDAMED and EU medical device regulations. The European Commission periodically publishes guidance documents and updates on the implementation of EUDAMED.
It's important to note that EUDAMED underwent significant changes and updates as part of the implementation of the new EU medical device regulations (MDR and IVDR). Manufacturers should consult with regulatory experts and stay informed about the latest requirements and timelines for compliance with EUDAMED.
