Categorization and Registration Process for Devices in EUDAMED

Categorization of Devices

Categorization of devices to be registered in EUDAMED include:

1. Regulation Devices – Regulation Devices are defined as medical devices and in vitro diagnostic medical devices that are placed on the market under Regulation (EU) 2017/745 (MDR) or Regulation 2017/746 (IVDR)
2. Legacy Devices – Legacy devices are defined as medical devices, active implantable medical devices and in vitro diagnostic medical devices – covered by a valid Directive certificate – that will continue to be placed on the market after the date of application of Regulation (EU) 2017/745 (MDR) or Regulation 2017/746 (IVDR).
3. Other Devices – ‘Custom-made devices’ and ‘Devices older than legacy devices’ are reported and registered only in Vigilance reports (in the Vigilance module).

Registration Process for Regulation Devices

A manufacturer shall start the registration process as mentioned below:

1. Basic UDI-DI Identification – Choose the legislation, enter the Issuing entity with the Basic Unique Device Identification –Device Identification value and some special characteristics
2. Basic UDI-DI Information – Enter basic UDI-DI attributes information
3. Certificate Information – Enter certificate information (if applicable – only for MDR class III, class IIB, and IVDR class D, C, and B with self-testing or near-patient testing
4. UDI-DI Information – Enter issuing entity with the UDI-DI value, the nomenclature code, UDI-DI information, and characteristics
5. Container-Packager Information – Add container packager information if applicable
6. Device is submitted and registered
7. For high-risk class devices, covered by a Type Examination or Technical Documentation Certificate (for devices referred to in MDR Art 29(3) or in IVDR Art 26(2)) requires the Notified Body confirmation of device data before the device can be publicly available.