The new MDR 2017/745 and IVDR 2017/746 EU regulations introduce an EU identification system for medical devices based on a Unique Device Identifier (UDI) and require that manufacturers of medical devices submit the UDI/Device information of all devices/products that they place on the market.
The UDI-DI/Device module of EUDAMED is used for this purpose.
MDR 2017/745 further states that ‘Natural or legal persons shall draw up a statement if they combine devices bearing a CE marking with the following other devices or products, in a manner that is compatible with the intended purpose of the devices or other products and within the limits of use specified by their manufacturers, in order to place them on the market as a system or procedure pack’. EUDAMED allows system or procedure pack producers to register their packs in a similar manner as manufacturers register their devices.
A step-by-step guide will guide you through the respective registration processes. Please make sure that you understand all concepts and have all information at hand before starting to register a new UDI/device or a system or procedure pack (SPP).