EUDAMED FAQ
Q: What is EUDAMED?
A: EUDAMED stands for the European Database on Medical Devices. It is the IT system developed by the European Commission to implement the regulations for medical devices (MDR 2017/745) and in vitro diagnostic medical devices (IVDR 2017/746).
Q: What is its purpose?
A: EUDAMED serves as a centralized repository of information related to medical devices placed on the market in the European Union (EU). It consists of six interconnected modules and a public website, covering various aspects of medical device regulation and oversight.
Q: What are the EUDAMED modules?
A: The six interconnected modules of EUDAMED are Actor Registration (ACT), Unique Device Identification/Devices Registration (UDI), Notified Bodies and Certificates (CRF), Clinical Investigations and Performance Studies (CIPS), Vigilance and Post-Market Surveillance (VGL) and Market Surveillance (MSU).
Q: What information do the modules store?
- Actor Registration (ACT) allows actors such as manufacturers, importers, and authorized representatives to register, and it provides a unique identification number (SRN) to each registered actor.
- Unique Device Identification/Devices Registration (UDI) contains device-specific information, including Basic UDI-DI for product groups and UDI-DI for individual products. It is the responsibility of Economic Operators to manage UDI attributes and transfer the data to EUDAMED.
- Notified Bodies and Certificates (CRF) stores certificates issued by Notified Bodies for Quality Management System and Conformity Assessment. It facilitates communication between Notified Bodies and monitors clinical evaluation consultation procedures.
- Clinical Investigations and Performance Studies (CIPS) manages data related to clinical investigations and performance evaluation of medical devices, including follow-ups, post-market changes, reports, and trials.
- Vigilance and Post-Market Surveillance (VGL) handles submissions of safety reports such as Periodic Safety Update Reports (PSUR), Periodic Summary Reports (PSR), incidents, and corrective actions.
- Market Surveillance (MSU) facilitates cooperation and coordination among competent authorities of EU Member States for market surveillance activities.
Q: What is the current implementation status of EUDAMED?
A: The Actor Registration (ACT) module, Unique Device Identification/Devices Registration (UDI) and Notified Bodies and Certificates (CRF) modules are all available. However, the remaining modules, including Clinical Investigations and Performance Studies (CIPS), Vigilance and Post-Market Surveillance (VGL), and Market Surveillance (MSU), are yet to be fully launched.
Q: What are GMDN and EDMN codes?
A: GMDN stands for Global Medical Device Nomenclature codes, and EDMN stands for European Medical Device Nomenclature codes. The EDMN codes will replace the current GMDN codes. These codes are alphanumeric and are used to identify medical devices and their characteristics, including the device type, and intended use. EDMN terms are drafted more widely, covering multiple types of medical devices under one term, providing a more comprehensive classification.
Q: How are EDMN codes used in EUDAMED?
A: The EDMN codes will be used in EUDAMED to classify medical devices and facilitate the exchange of information between different stakeholders. They will help ensure that the correct device is used for its intended purpose and that relevant information is available to regulatory authorities and other stakeholders.
Q: Do manufacturers have to use EUDAMED now?
A: Manufacturers can voluntarily use the available EUDAMED modules before the full implementation. While EUDAMED is not yet mandatory, manufacturers can choose to use the available modules to familiarize themselves with the system and its functionalities. However, once the entire EUDAMED system, including all six modules, becomes fully operational, its use will become mandatory for all manufacturers of Medical Devices in the EU.
UDI Beginners Guide
Risk Management
