Categorization and Registration Process for Devices in EUDAMED

Device Categorization

Devices submitted for registration in EUDAMED fall under the following categories:

1. Regulation Devices – These include medical devices and in vitro diagnostic (IVD) devices placed on the market in accordance with Regulation (EU) 2017/745 (MDR) or Regulation (EU) 2017/746 (IVDR).
2. Legacy Devices – These are medical devices, active implantable devices, and IVDs that continue to be marketed under valid Directive certificates after the MDR and IVDR become applicable.
3. Other Devices – Custom-made devices and devices older than legacy devices. These are only reported and registered through vigilance submissions within the Vigilance module.

Registration Procedure for Regulation Devices

Manufacturers must follow these steps when registering Regulation Devices in EUDAMED:

1. Basic UDI-DI Identification:- Select the applicable legislation and provide the issuing entity along with the Basic UDI-DI value and any device-specific characteristics.
2. Basic UDI-DI Information:- Enter all required attributes associated with the Basic UDI-DI.
3. Certificate Information:- Upload certificate details where applicable. This step applies to MDR Class III, MDR Class IIb, and IVDR Class D, C, and B devices that involve self-testing or near-patient testing.
4. UDI-DI Information:- Provide the issuing entity, UDI-DI value, nomenclature code, and all relevant UDI-DI attributes and characteristics.
5. Container/Packaging Information:- Add packaging details when relevant.
6. Final Submission:- After completing all entries, the device can be submitted for registration.

For high-risk class devices covered by a Type Examination Certificate or Technical Documentation Certificate (as described in MDR Article 29(3) and IVDR Article 26(2)), the Notified Body must verify and confirm the device information before it becomes publicly accessible in EUDAMED.