IVDR Declaration of Conformity Form
Complete this form to document an IVDR Declaration of Conformity for your IVD device. All information must be accurate and pertain to the device's conformity with the declared requirements.
Manufacturer Name and Contact Details
*
Authorized Representative Details (if applicable)
Device Name and Model/Type
*
Device Class
*
Please Select
Class A
Class B
Class C
Class D
UDI-DI or Equivalent Device Identifier
*
Intended Purpose of the Device
*
Applicable Conformity Assessment Route
*
Please Select
Annex IX – Quality Management System and Assessment
Annex X – Type Examination
Annex XI – Production Quality Assurance
Other (specify in intended purpose)
Declaration Date
*
-
Month
-
Day
Year
Date
Place of Declaration
*
Submit Declaration
Should be Empty: