What Is EUDAMED?
The European Union created EUDAMED (European Database on Medical Devices), a centralized database, to improve the safety, traceability, and transparency of medical devices and in vitro diagnostic (IVD) devices throughout Europe. It is an essential part of the EU’s In Vitro Diagnostic Regulation (IVDR) and Medical Device Regulation (MDR).
Purpose of EUDAMED
Enhancing patient safety and bolstering EU regulatory oversight of medical devices are the main goals of EUDAMED. By centralizing data, EUDAMED makes it easier for manufacturers, regulatory agencies, notified bodies, and medical professionals to exchange information and better monitor devices throughout their lifecycle.
Key Modules of EUDAMED
- Module for Actor Registration Manufacturers, importers, and authorized representatives are among the economic operators registered by this module. Actors are assigned a Single Registration Number (SRN) upon registration.
- Module for UDI/Device Registration It ensures device traceability from manufacture to patient use by storing core device data and Unique Device Identification (UDI).
- Module for Notified Bodies and Certificates Conformity assessment certificates, notified bodies, and associated documentation are all covered in this module.
- Post-Market Surveillance and Vigilance Module In order to facilitate continuous safety monitoring, serious incidents, field safety corrective actions (FSCAs), and trend reports are documented here.
- Module for Clinical Research and Performance Studies Data from clinical research and performance studies carried out in the EU are collected by this module.
Regulatory Importance of EUDAMED
It is mandated by EU MDR (Regulation (EU) 2017/745) and IVDR (Regulation (EU) 2017/746). To preserve compliance and market access within the EU, manufacturers must guarantee timely and accurate data entry.
Benefits of EUDAMED
It strengthens patient safety, increases transparency, and improves device traceability. By offering a single, standardized platform for medical device data throughout Europe, it also streamlines regulatory oversight.
By promoting safety, compliance, and transparency, itis essential to the EU’s medical device regulatory framework. Manufacturers can effectively handle EUDAMED registrations, submissions, and continuing regulatory obligations with Masuu Global’s professional assistance, guaranteeing seamless access to European markets.