What is EUDAMED?
EUDAMED Definition
EUDAMED is a centralized European database used to collect information about medical devices and their manufacturers. EUDAMED is a key component of the MDR 2017/745 and IVDR 2017/746 regulations. It was designed with the intent to strengthen market surveillance and transparency with regard to medical devices in the EU market. The database provides information related to actor registration, unique device identifier (UDI), device registration, notified bodies and certificates, clinical investigations and performance studies, vigilance and market surveillance.
FAQs
What is the EUDAMED database?
EUDAMED is the European database for medical devices. It’s a secure, web-based portal that acts as a central hive for the exchange of information between national competent authorities and the European Commission. It is intended to track the safety and performance of medical devices in accordance with the EU Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR).
Who can access EUDAMED?
EUDAMED is accessible to competent authorities as well as economic operators who are registered in accordance with the MDR and IVDR. Economic operators include:
- Manufacturers
- Authorized Representatives
- Importers
What are the 6 EUDAMED modules?
The EUDAMED database consists of six interrelated modules:
- Actor Registration – Enables economic operators (i.e., manufacturers, authorized representatives, and importers) to register their information
- Unique Device Identification (UDI) – Maintains device-specific information. Economic operators are responsible for managing all UDI attributes and transferring the data to EUDAMED
- Certificates – Maintains EU certificates for each product group
- Clinical Investigation – Maintains information regarding the collection and analysis of clinical data
- Vigilance – Maintains serious incident reports
- Market Surveillance – Maintains post-market surveillance reports
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