1.Medical Device development and lifecycle management under the MDR and IVDR

The goal of the D&D phase is to demonstrate that the device:

• • is safe to use                                                                                         
  • meets the user needs                                                                       
  • meets legal requirements
  • specifications meet the functional requirements,
  • can be manufactured with the available resources

The complete D&D trajectory

• • should follow an approved D&D plan
  • contains all information documented in the D&D files, e.g,
    • risk management,
    • clinical evaluations,
    • document control, training, etc. 

• • contains a Quality Management System (QMS):
    • includes verification and validation to determine if there is objective evidencethat both the design inputs (verification) and intended use (validation) are met,    
    • clinical evaluations
    • documented within the QMS as part of the D&D files.

• • Design transfer includes among others
    • the development and validation of manufacturing processes, upscaling
    • trainings,
    • supplier products specifications,
    • maintenance instructions.

In parallel with the D&D process, the registration process takes place in which the technical documentation is prepared that demonstrates the conformity of the device with the technical requirements of the MDR (according to Annex II and III, MDR) and prior to drawing up the EU declaration of conformity.