The European Database on Medical Devices (EUDAMED) is an essential platform established under the Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746).
It serves to enhance transparency, improve market surveillance, and facilitate regulatory compliance for medical device (MD) and in vitro diagnostic (IVD) manufacturers operating in the European Union (EU).
At EUmAccess GmbH, we assist manufacturers, importers, and other economic operators in navigating the EUDAMED registration process, ensuring full compliance with EU regulatory requirements.
What is EUDAMED?
EUDAMED is a centralized European database designed to improve coordination and information exchange between EU Competent Authorities, Notified Bodies, and Economic Operators. It consists of six interconnected modules:
Actor Registration (Mandatory)
All manufacturers, authorized representatives, and importers must be registered in EUDAMED.
UDI/Device Registration
Unique Device Identification (UDI) and product details must be uploaded.
Notified Bodies & Certificates
Records of CE certificates issued by Notified Bodies.
Clinical Investigations & Performance Studies
Documentation of clinical and performance evaluations.
Market Surveillance & Vigilance
Reporting of serious incidents and corrective actions
Post-market Surveillance & Trend Reporting
Compliance monitoring and reporting.
Our EUDAMED Registration Services
Actor Registration Support
We guide manufacturers, EU Authorised Representatives (E.A.R), and importers through the actor registration process, ensuring compliance with SRN (Single Registration Number) requirements.
UDI/Device Registration Assistance
We help register your medical devices and IVDs, ensuring accurate submission of Unique Device Identification (UDI) information.
Regulatory Document Preparation
Our team ensures your documentation aligns with EUDAMED requirements, minimizing the risk of delays or rejections.
Data Submission & Compliance Checks
We review and validate your data to ensure full compliance before submission.
Ongoing Regulatory Support
Keeping you updated on EUDAMED implementation phases and helping you stay compliant with evolving requirements.
Ensure Seamless EUDAMED Compliance with EUmAccess GmbH
Avoid registration delays and regulatory risks. Let EUmAccess GmbH handle your EUDAMED registration while you focus on bringing safe and effective medical devices to the European market.
Drop here a note
contact@eumaccess.com
Call us Directly
+49 621-76-44-10-101
Drop here a note
contact@eumaccess.com
Call us Directly
+49 621-76-44-10-101
EUmAccess GmbH
At EUmAccess GmbH, we specialize in providing expert regulatory and compliance solutions to businesses with a focus on the Medical Devices (MD) and In Vitro Diagnostic (IVD) sectors, we assist manufacturers in navigating the complex regulatory landscape, ensuring smooth market entry and compliance with EU directives and regulations.