Glossary

EUDAMED

What is EUDAMED?

EUDAMED (European Database on Medical Devices) is an IT system developed by the European Commission to implement the Medical Devices Regulation (EU) 2017/745 and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746. It serves as a central repository for information on medical devices and their regulatory status within the European Union.

What are the main functions of EUDAMED?

EUDAMED is structured around six interconnected modules that facilitate various aspects of medical device regulation, including:

  • Actors Registration: Registration of economic operators involved in the medical device supply chain
  • UDI/Devices Registration: Unique Device Identification (UDI) and device registration
  • Notified Bodies and Certificates: Information on notified bodies and their issued certificates
  • Clinical Investigations and Performance Studies: Data on clinical trials and performance evaluations
  • Vigilance and Post-Market Surveillance: Reporting of adverse events and monitoring of devices post-market
  • Market Surveillance: Oversight of market activities related to medical devices

How does EUDAMED enhance transparency in the medical device market?

EUDAMED enhances transparency by providing a centralized database that allows for easier access to information about medical devices, their manufacturers, and their regulatory status. This visibility helps stakeholders, including healthcare professionals and patients, make informed decisions.

What is the significance of the Unique Device Identification (UDI) in EUDAMED?

The UDI system is crucial for improving the traceability of medical devices throughout the supply chain. It allows for better identification and monitoring of devices, facilitating quicker responses to safety issues and recalls.

What are the implications of EUDAMED for manufacturers and economic operators?

Manufacturers and economic operators will need to register their information in EUDAMED, maintain up-to-date records, and comply with the requirements for reporting adverse events and other relevant data. This will enhance their accountability and ensure compliance with EU regulations.