Support on the EUDAMED platform
EUDAMED (European Database on Medical Devices) is a centralised system developed by the European Union to enhance transparency, traceability, and oversight in the medical devices sector.
It is an integral part of the implementation of Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), serving as a key tool for competent authorities, notified bodies, manufacturers, importers, authorised representatives, and the general public.
We provide full support in the registration and data submission process in EUDAMED, ensuring compliance with all applicable legal and technical requirements.
Our services include:
Registration
Registration of economic operators (manufacturers, importers, authorised representatives) and acquisition of the SRN (Single Registration Number)
Support
Support with the submission of information on medical devices and IVDs, including:
Assignment and validation of the UDI-DI (Unique Device Identifier)
Registration of devices and associated certificates
Assistance
Assistance with updating and ongoing maintenance of registered information
Verification of compliance
Verification of compliance with interoperability and technical format requirements as defined by the European Commission
