Classification
Single-use vs reusable
Choosing the right classification for your market is a regulatory decision.
| Factor | Single-use | Reusable |
|---|---|---|
| Regulatory class (EU) | Class I or IIa (sterile) | Class I or IIa |
| Sterilisation | EO or gamma – pre-packed | Autoclave-compatible |
| Documentation | Sterility validation required | Reprocessing instructions |
| Packaging | Peel pouch / blister | Tray or rigid case |
| Price point | Lower unit cost | Higher unit cost, reused |