European Medical Device Nomenclature (EMDN) This helpdesk also provides support as regards the use of the European Medical Devices Nomenclature (EMDN). The UDI helpdesk provides support to economic operators in the implementation of the obligations and requirements introduced by the new UDI system, including UDI assignment, labelling and registration of devices. DTX service definition for economic operators v2.0.UDI Device enumerations v2.0 - This document contains the value lists for drop down elements and lists where a limited set of values can be selected.UDI Device Business rules v2.0 - This document contains the constraints, limitations and business rules that drive the implementation of EUDAMED.EUDAMED UDI/Device data dictionary V8.0 - This document clarifies the data to provide in EUDAMED for the UDI device registration module.Overview of the MDR UDI and device data sets and IVDR UDI and device data sets to provide for their registration in EUDAMED Technical documentation UDI/Devices User Guide for Economic Operators.
Relevant documents and links on UDI/Device registration are published below. Therefore, additional national requirements on registrations cannot be excluded. The European Commission is not in a position to require the use of the UDI/Devices registration module until EUDAMED is fully functional according to the Medical Device Regulation. Manufacturers can already enter UDI/Device information in the system on a voluntary basis.
This requires that manufacturers submit in EUDAMED the UDI/Device information of all devices they place on the EU market. Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices introduce an EU device identification system based on a unique device identifier (UDI) allowing easier traceability of medical devices.
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