EUDAMED
Table of Contents
Introduction
EUDAMED (European Database on Medical Devices) is a centralized database developed by the European Union to ensure transparency and harmonization in the regulation of medical devices and in vitro diagnostic devices. It plays a pivotal role in the implementation of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
Definitions and Concepts
EUDAMED: A secure and web-based portal that allows for the storage and exchange of information regarding medical devices within the EU.
MDR: The European Medical Device Regulation (2017/745), which outlines the safety and performance requirements for medical devices sold in the EU.
IVDR: The In Vitro Diagnostic Regulation (2017/746), developed for in vitro diagnostic medical devices within the EU.
Actors Registry: An integral module of EUDAMED where all economic operators (manufacturers, authorized representatives, importers) must register.
Importance
EUDAMED is crucial for ensuring patient safety, enhancing the traceability of medical devices, and improving regulatory oversight across Europe. It promotes transparency by providing comprehensive access to relevant data for regulatory authorities, manufacturers, healthcare professionals, and the public. In the pharmaceutical and biotech industries, it ensures integration and harmonization of device-related processes critical for combined medicinal device products.
Principles or Methods
- Modular Structure: The database comprises six interconnected modules: Actors Registration, UDI/Device Registration, Notified Bodies and Certificates, Clinical Investigations, Vigilance and Post-Market Surveillance, and Market Surveillance.
- Unique Device Identification (UDI): Each medical device is assigned a UDI to improve traceability and ensure compliance with MDR and IVDR requirements.
- Data Accessibility: Strict access controls define who can view or contribute data, ensuring confidentiality for sensitive information while promoting transparency.
- Compliance Integration: Alignment with existing regulatory and quality frameworks like ISO 13485 for smooth device-to-regulatory transitions.
Application
- Medical Device Manufacturers: Use EUDAMED for registering devices, submitting vigilance reports, and obtaining regulatory approvals faster.
- Regulatory Bodies: Monitor compliance, conduct post-market surveillance, and streamline audits using consistent and centralized data.
- Healthcare Professionals: Access reliable and updated device data for informed medical decision-making.
- Life Sciences & Biotech Sectors: Ensure compliance for combination products (e.g., drug-device or biologic-device combinations), facilitating market entry and post-market tracking.
- Clinical Investigators: Register and manage clinical investigations more transparently and in alignment with European regulations.
