Step 1: Old/custom-made device information
The fields displayed on this page depend on the selected option for the Applicable legislation field in the Step 0: Old/custom-made device registration page.
Complete the fields in this section by referring to the table at the bottom of the page.
Click the Submit button:
A pop-up window is displayed. Click Confirm to register the old/custom-made device:
Your old/custom-made registration request was successfully submitted.
The following table summarises the displayed fields per applicable legislation.
Legislation/ Fields | MDR | IVDD | MDD | AIMDD | NONE | UNKNOWN |
|---|---|---|---|---|---|---|
Device is custom-made | ✓ Set to Yes and non-editable | ✓ | ✓ | ✓ | ✓ | ✓ |
Is it a System or Procedure Pack which is a Device in itself? | ✓ | ✓ | ✓ | |||
Is it a kit | ✓ | |||||
Special device type | ✓ Mandatory if No is selected for the Is it a System or Procedure Pack which is a Device in itself? field | ✓ Mandatory if No is selected for the Is it a kit field | ✓ Mandatory if No is selected for the Is it a System or Procedure Pack which is a Device in itself? field | ✓ Mandatory if No is selected for the Is it a System or Procedure Pack which is a Device in itself? field | ||
Risk class | ✓ | ✓ | ✓ | ✓ | ||
Implantable | ✓ | ✓ | ✓ | |||
Measuring function | ✓ | ✓ | ✓ | |||
Reusable surgical instruments | ✓ | ✓ | ✓ | |||
Active device | ✓ | ✓ | ✓ | |||
Device intended to administer and/or remove medicinal product | ✓ | ✓ | ✓ | |||
Near-patient testing | ✓ | |||||
Self-patient testing | ✓ | |||||
Companion diagnostic | ✓ | |||||
Reagent | ✓ | |||||
Instrument | ✓ | |||||
Professional testing | ✓ | |||||
Device model | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
Device name | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
Trade name | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
Select the language | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
Reference/Catalogue number | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
Device status | ✓ | ✓ Set to No longer placed on the EU market and non-editable if No is selected for the Device is custom-made field | ✓ Set to No longer placed on the EU market and non-editable if No is selected for the Device is custom-made field | ✓ Set to No longer placed on the EU market and non-editable if No is selected for the Device is custom-made field | ✓ | ✓ |
Device labelled as sterile | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
Presence of human tissues or cells, or their derivatives | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
Intended purpose other than medical (Annex XVI) | ✓ | |||||
Presence of substance which, if used separately, may be considered to be a medical product | ✓ | ✓ | ✓ | |||
Presence of substance which, if used separately, may be considered to be a medical product derived from human blood or human plasma | ✓ | ✓ | ✓ | |||
Member states where the device is or is to be made available on the market | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
Note
If No is selected for the Device is custom-made field, the user must check the box for the field I confirm that this device has no longer been placed on the EU market after the date of the application of the MDR/IVDR to confirm that the device is considered 'old'. Otherwise, the old/custom-made device registration will not be possible.
Note
For certain mandatory fields, the user can select the Unknown option. When creating a new version of the old/custom-made device, these fields cannot be edited unless the Unknown option is selected.