What is EUDAMED?
EUDAMED (European Database on Medical Devices) is a key component of the EU's regulatory framework for medical devices, established under the Medical Devices Regulation (MDR) (Regulation (EU) 2017/745) and the In Vitro Diagnostic Medical Devices Regulation (IVDR) (Regulation (EU) 2017/746). It is designed to enhance transparency, traceability, and coordination among stakeholders in the medical device industry.
They provide:
- Improve Transparency: Provide public access to essential information about medical devices and their compliance status.
- Enhance Traceability: Ensure that devices can be tracked throughout their lifecycle.
- Support Surveillance: Enable authorities to monitor safety, performance, and market surveillance activities effectively.
- Streamline Communication: Facilitate communication between economic operators (manufacturers, authorized representatives, importers), notified bodies, and regulatory authorities.
Promote Patient Safety: Provide access to critical safety information, helping healthcare providers and patients make informed decisions.
How to utilize EUDAMED for searching?
- Registered Devices: Information on medical devices that have been registered.
- Economic Operators: Details on manufacturers, authorized representatives, and importers.
- Certificates: Valid certificates issued under the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
- Notified Bodies: Details about Notified Bodies responsible for conformity assessments.
Users can search using:
- Device identification information (e.g., UDI-DI, Basic UDI-DI).
- Economic operator details (e.g., name, country).
- Certificate numbers or notified body names.
Current Status of EUDAMED's Functionalities
EUDAMED has not been fully implemented due to delays. Some modules are operational while others are still in development or testing phases. The operational modules include:
- Actor Registration Module.
- UDI/Device Registration Module (public database pending full activation)
- Notified Body and Certificates Module.
- The vigilance, clinical investigation, and market surveillance modules are still under development, with the full database expected to be operational by 2026.
What Kinds of Information Can you Get?
Depending on the activated modules, you can access:
- Device Information:Basic UDI-DI and device attributes.
Risk classification, intended use, and conformity assessment details.
- Certificates: Information on issued, suspended, or withdrawn certificates.
- Economic Operators: Details of registered manufacturers, authorized representatives, and importers.
- Notified Bodies: Details of conformity assessment bodies, including their scope.
Do You Need to Join EUDAMED to Acceess Information?
- Public Access:
A significant portion of EUDAMED’s data will be accessible through its public interface without the need for registration (e.g., device registrations and certificates).
- Restricted Access:
For sensitive or restricted data (e.g., clinical investigation or detailed vigilance reports), only authorized actors (e.g., manufacturers, regulators) with proper credentials can access it.
Joining requires registering as an Economic Operator or authorized actor.
Next tjme, we are going to review what kinds of medical device have been approved by MDR and how to join as economic operator.