Scientific Committee Review Requirements
Certain variations trigger Scientific Committee review, ensuring safety and performance.
When Review is Required
- Sterile accessories
- High-risk or significant device changes
- Products from non-reference countries
Required Documentation
- Technical files, risk assessments, GMP certificates
- Stability, biocompatibility, and sterilization data
- Updated labeling/IFU
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.
