UDI (Unique Device Identification) Assignment and Management
The Unique Device Identification (UDI) system, introduced by Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), aims to enhance the traceability, safety, and transparency of medical and in vitro diagnostic devices across the European market.
UDI implementation is mandatory for all medical devices, regardless of their class (I, IIa, IIb, III), and requires the correct assignment, validation, and registration of UDI codes in the EUDAMED database according to the timelines defined by the regulations.
We provide full support in managing the entire UDI process, ensuring that your devices meet all technical and regulatory requirements, helping to avoid delays in market access and reducing the risk of non-compliance.
Our services include
Ensure the correct assignment and timely submission of UDI
Ensure the correct assignment and timely submission of UDI codes in accordance with regulatory deadlines
Minimise the risk of non-compliance
Minimise the risk of non-compliance, avoiding penalties and potential barriers to market placement
Efficiently integrate UDI into your internal processes
Efficiently integrate UDI into your internal processes and required EU regulatory platforms
