Certain variations trigger Scientific Committee review, ensuring safety and performance.
01
When Review is Required
Sterile accessories High-risk or significant device changes Products from non-reference countries
02
Required Documentation
Technical files, risk assessments, GMP certificates Stability, biocompatibility, and sterilization data Updated labeling/IFU
03
Operational Implications
Extended timelines Strategic submission planning Example: Sterilization process change for pen needles in a combination product must include full committee documentation to avoid delays.
