Changes in design for medical
devices other than IVDs


Category (Significant, non-significant)

All changes to the control mechanisms, operating principles and/or design characteristics of a medical device, such as:

  • Change from a quantitative assay to a qualitative assay
  • Addition of a footswitch to an X-ray system that previously do not operate via a footswitch mechanism.
  • Change of an RIA test to an ELISA test.

Change in the design characteristics that allows for additional or broader intended use, such as:

  • A smaller sized hip prosthesis or fracture fixation screw that are significantly different from their predicate designs.
  • Addition of urine as specimen in the intended use for creatinine test


Change that have Pre-clinical and/or clinical data identified new risks that adversely affects the safety and/or performance of the device, such as:

  • The original heat-sealing package barrier found risk of leakage and change to sterile packaging barrier

Change results of a risk analysis undertaken during the design validation process raise new issues of safety and/or performance, such as:

  • Change from an internal direct current (DC) power source to an external alternating current (AC) source or vice versa
  • During the clinical validation process, ceramic dental cap has found durability issues, other materials has to be considered Change to the cable design and grip of a steerable ablation catheter, which results in improved deliverability and improved procedural times.

Change to the design, manufacturing or components that change its intended performance, such as:

  • All changes in specifications (including shelf life and stability) of an IVD medical device

Change of the secondary packaging

Non - Significant
Change of colour of the cap of a reagent

Non - Significant
Changes of smartphones and computers (including tablet PC) running medical software that does not accompany changes in the software

Non - Significant
Changes of storage media (CD, USB, Web, etc.) of the standalone software that does not accompany changes in the software

Non - Significant